ISO 11193-2 KS

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Part 2:
© KEBS 2008
chloride)
KENYA STANDARD
Specification for gloves made from poly(vinyl

Single-use medical examination gloves —
First Edition 2008

KS ISO 11193-2: 2006
ICS 11.140
KS ISO 11193-2: 2006
TECHNICAL COMMITTEE REPRESENTATION
The following organizations were represented on the Technical Committee:
Government Chemists Department

Kam Industries Ltd
Nairobi Hospital
Kenya Medical Research Institute (KEMRI)
City Council of Nairobi, Department of Public Health
Christian Health Association of Kenya (CHAK)
Kenya Medical Association (KMA)
Kenya Bureau of Standards — Secretariat
Licensed by KEBS. Limited Access during COVID-19 Emergency. Personal use only
REVISION OF KENYA STANDARDS

In order to keep abreast of progress in industry, Kenya Standards shall be regularly reviewed.
Suggestions for improvements to published standards, addressed to the Managing Director, Kenya
Bureau of Standards, are welcome.
© Kenya Bureau of Standards, 2008
Copyright. Users are reminded that by virtue of Section 25 of the Copyright Act, Cap. 12 of 2001 of the Laws of Kenya,
copyright subsists in all Kenya Standards and except as provided under Section 26 of this Act, no Kenya Standard produced by
Kenya Bureau of Standards may be reproduced, stored in a retrieval system in any form or transmitted by any means without
prior permission in writing from the Managing Director.
ii © KEBS 2008 — All rights reserved

KENYA STANDARD KS ISO 11193-2: 2006
ICS 11.140

Part 2:
Specification for gloves made from poly(vinyl

chloride)
KENYA BUREAU OF STANDARDS (KEBS)

Head Office: P.O. Box 54974, Nairobi-00200, Tel.: (+254 020) 605490, 602350, Fax: (+254 020) 604031
E-Mail: info@kebs.org, Web:http://www.kebs.org
Coast Region Lake Region Rift Valley Region

P.O. Box 99376, Mombasa-80100 P.O. Box 2949, Kisumu-40100 P.O. Box 2138, Nakuru-20100
Tel.: (+254 041) 229563, 230939/40 Tel.: (+254 057) 23549, 22396 Tel.: (+254 051) 210553, 210555
Fax: (+254 041) 229448 Fax: (+254 057) 21814
© KEBS 2008 — All rights reserved iii

KS ISO 11193-2: 2006
NATIONAL FOREWORD
This Kenya Standard was prepared by the Hospital Equipment Technical Committee, under the guidance of
the Health Services Industry Standards Committee, and it is in accordance with the procedures of the Kenya
Bureau of Standards.
This standard is identical to and has been reproduced from ISO 11193, Single-use medical examination
gloves, Part 2: Specification for gloves made from poly(vinyl chloride), published by the International
Organization for Standardization (ISO). The National Standards Council has endorsed the adoption of the
2002 edition of this standard as a Kenya Standard.
References
For the purposes of this standard, references to International Standards should be replaced by references
to the appropriate Kenya Standards, where they have been declared.
iv © KEBS 2008 — All rights reserved

INTERNATIONAL ISO
STANDARD 11193-2
First edition
2006-11-01

Part 2:
Specification for gloves made from

poly(vinyl chloride)
Gants en caoutchouc pour examen médical, non réutilisables —
Partie 2: Spécifications pour gants fabriqués en chlorure de polyvinyle
Reference number
ISO 11193-2:2006(E)
© ISO 2006
ISO 11193-2:2006(E)
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Published in Switzerland
ii © ISO 2006 – All rights reserved

ISO 11193-2:2006(E)
Contents Page
Foreword............................................................................................................................................................ iv
1 Scope ..................................................................................................................................................... 1
2 Normative references ........................................................................................................................... 1
3 Classification......................................................................................................................................... 2
4 Materials ................................................................................................................................................ 2
5 Sampling and selection of test pieces................................................................................................ 2
6 Requirements ........................................................................................................................................ 3
7 Packaging .............................................................................................................................................. 4
8 Marking .................................................................................................................................................. 4
Annex A (normative) Test for watertightness ................................................................................................. 8
© ISO 2006 – All rights reserved iii

ISO 11193-2:2006(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 11193-2 was prepared by Technical Committee ISO/TC 45, Rubber and rubber products, Subcommittee
SC 4, Products (other than hoses).
This part of ISO 11193, together with ISO 11193-2, cancels and replaces ISO 11193:1994, which has been
technically revised.
ISO 11193 consists of the following parts, under the general title Single-use medical examination gloves:
— Part 1: Specification for gloves made from rubber latex or rubber solution
— Part 2: Specification for gloves made from poly(vinyl chloride)
iv © ISO 2006 – All rights reserved

INTERNATIONAL STANDARD ISO 11193-2:2006(E)

Part 2:
Specification for gloves made from poly(vinyl chloride)
WARNING — Persons using this International Standard should be familiar with normal laboratory
practices. This standard does not purport to address all of the safety problems, if any, associated with
its use. It is the responsibility of the user to establish appropriate safety and health practices and to
ensure compliance with any regulatory conditions.
1 Scope
This part of ISO 11193 specifies requirements for packaged sterile, or bulked non-sterile, poly(vinyl chloride)
gloves intended for use in medical examinations, and diagnostic or therapeutic procedures, to protect the
patient and the user from cross-contamination. It also covers poly(vinyl chloride) gloves intended for use in
handling contaminated medical materials.
This part of ISO 11193 is intended as a reference for the performance and safety of poly(vinyl chloride)
examination gloves. The safe and proper usage of examination gloves and sterilization procedures with
subsequent handling, packaging and storage procedures are outside the scope of this part of ISO 11193.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 37:2005, Rubber, vulcanized or thermoplastic — Determination of tensile stress-strain properties
ISO 188, Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests
ISO 2859-1, Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by
acceptance quality limit (AQL) for lot-by-lot inspection
ISO 10993 (all parts), Biological evaluation of medical devices
ISO 15223, Medical devices — Symbols to be used with medical device labels, labelling and information to be
supplied
ISO 23529, Rubber — General procedures for preparing and conditioning test pieces for physical test
methods
© ISO 2006 – All rights reserved 1

ISO 11193-2:2006(E)
3 Classification
Gloves are classified by finish as follows:
a) textured surface over part or all of the glove;
b) smooth surface;
c) powdered surface;
d) powder-free surface.
NOTE 1 Powdered gloves are gloves where a powder has been added as a part of the manufacturing process,
generally to facilitate donning. Powder-free gloves are gloves which have been manufactured without the deliberate
addition of powdered materials to facilitate donning.
NOTE 2 The cuff termination of the glove may be cut or in the form of a rolled rim.
4 Materials
Gloves shall be manufactured from plasticized poly(vinyl chloride). To facilitate donning the gloves, any
surface treatment, lubricant, powder or polymer coating may be used.
Any pigment, surface treatment, lubricant, or powder used shall be non-toxic and shall be disclosed on
request. It is essential that substances used for surface treatment, which are capable of being transferred, are
bio-absorbable.
Gloves as supplied to the user shall comply with the relevant part(s) of ISO 10993. The manufacturer shall
make available, on request, data to support compliance with these requirements.
NOTE Limits of extractable plasticizers, residual chemicals and residual powder in gloves may be specified in future
editions of this part of ISO 11193, subject to the availability of relevant ISO standard test methods.
5 Sampling and selection of test pieces
5.1 Sampling
For reference purposes, gloves shall be sampled and inspected in accordance with ISO 2859-1. The
inspection levels and acceptance quality limits (AQLs) shall conform to those specified in Table 1 for the
characteristics listed.
When a lot size cannot be determined, a lot of 35 001 to 150 000 shall be assumed.
Table 1 — Inspection levels and AQLs
Characteristic Inspection level AQL
Physical dimensions (width, length, thickness) S-2 4,0

Watertightness G-1 2,5
Force and elongation at break S-2 4,0
5.2 Selection of test pieces
Where test pieces are required, they shall be taken from the palm or back of gloves.
2 © ISO 2006 – All rights reserved

ISO 11193-2:2006(E)
6 Requirements
6.1 Dimensions
When measured at the points shown in Figure 1, gloves shall comply with the dimensions for palm width and
length given in Table 2, using the inspection level and AQL given in Table 1.
The measurement of length shall be the shortest distance between the tip of the second finger and the cuff
termination.
NOTE The length measurement may be taken by hanging the glove on a suitable mandrel with a tip radius of 5 mm.
The measurement of width shall be at the midpoint between the base of the index finger and the base of the
thumb. The width measurement shall be made with the glove placed on a flat surface.
The thickness of the double wall of an intact glove shall be measured in accordance with ISO 23529, with a
pressure on the foot of 22 kPa ± 5 kPa, at each of the locations shown in Figure 2: a point of 13 mm ± 3 mm
from the extreme tip of the second finger and the approximate centre of the palm. The single-wall thickness at
each point shall be reported as half the measured double-wall thickness and shall comply with the dimensions
given in Table 2, using the inspection level and AQL given in Table 1.
If visual inspection indicates the presence of thin spots, the measurements shall be made in that area using a
single-wall thickness. The thickness at the smooth area and textured area of a single-wall when measured as
described in this subclause, using a test piece cut from the glove, shall be not less than 0,08 mm and
0,11 mm, respectively.
NOTE The thickness of the cuff termination measured in accordance with ISO 23529 should preferably not exceed
2,50 mm.
Table 2 — Dimensions and tolerances
Size Width Width Width by Minimum Minimum thickness Maximum thickness

code (dimensions (small, descriptive length (at the locations (at the approximate
w, Figure 1) medium or size (dimension l, shown in Figure 2) centre of the palm)
large) (dimensions Figure 1)
w, Figure 1)
mm mm mm mm mm
6 and u 82 Extra small u 80 220
below (X-S)
6 1/2 83 ± 5 Small (S) 80 ± 10 220
Smooth area: 0,08 Smooth area: 0,22
7 89 ± 5 230
Textured area: 0,11 Textured area: 0,23
7 1/2 95 ± 5 Medium (M) 95 ± 10 230
8 102 ± 6 230
8 1/2 109 ± 6 Large (L) 110 ± 10 230
9 and W 110 Extra large W 110 230
above (X-L)
6.2 Watertightness
When gloves are tested for watertightness as described in Annex A, the sample size and allowable number of
non-conforming (i.e. leaking) gloves in the sample shall be determined in accordance with the inspection level
and AQL given in Table 1.

ISO 11193-2:2006(E)
6.3 Tensile properties
6.3.1 General
Tensile properties shall be measured in accordance with ISO 37, taking three pieces from each glove and
using the median value as the test result. Test pieces shall be taken from the palm or back of gloves.
6.3.2 Force at break and elongation at break before accelerated ageing
When determined in accordance with the method specified in ISO 37, using type 2 dumb-bell test pieces, the
force at break and elongation at break shall comply with the requirements given in Table 3, using the
inspection level and AQL given in Table 1.
6.3.3 Force at break and elongation at break after accelerated ageing
Accelerated ageing tests shall be conducted in accordance with the method specified in ISO 188. Test
samples can either be prepared by ageing the gloves at 70 °C ± 2 °C for 168 h ± 2 h and then cut from the
aged gloves, or tensile samples can be cut from the gloves and then aged at 70 °C ± 2 °C for 168 h ± 2 h.
Tensile tests are then conducted as described in 6.3.2.
Table 3 — Tensile properties
Property Requirement
Minimum force at break before accelerated ageing, N 7,0

Minimum elongation at break before accelerated ageing, % 350
Minimum force at break after accelerated ageing, N 7,0
Minimum elongation at break after accelerated ageing, % 350
6.4 Sterility
If gloves have been sterilized, the nature of the sterilization process shall be disclosed on request.
7 Packaging
If gloves are sterilized, they shall be packed individually or in pairs.
8 Marking
8.1 General
Marking shall include a reference to this part of ISO 11193. Appropriate international symbols taken from
ISO 15223 may be used for labelling.
The language used for marking shall be as agreed upon between the interested parties.

ISO 11193-2:2006(E)
8.2 Unit package
8.2.1 Sterile package
The wrapping for each unit package of an individual glove or pair of gloves shall be clearly marked with the
following:
a) the name or trademark of the manufacturer or supplier;
b) the material used;
c) the words "TEXTURED" or "SMOOTH", "PRE-POWDERED" or "POWDER-FREE", or words to that effect

for the appropriate glove finish;
d) the size;
e) in the case of gloves that have been treated with any surface-dusting material, a warning note to the
effect that surface powder should be aseptically removed prior to use;
f) the manufacturer's identifying lot number;

g) the words "DATE OF MANUFACTURE" or words to that effect, and the year in four digits and month of
manufacture;
h) the words "STERILE UNLESS THIS PACKAGE IS OPENED OR DAMAGED";

i) the words "FOR SINGLE USE" or words to that effect;
j) the words "EXAMINATION GLOVE" (or “EXAMINATION GLOVES”) or "EXAM GLOVE" (or “EXAM
GLOVES”);
k) the words "Product contains plasticizers (the nature of the plasticizers shall be disclosed) that may be
harmful to users".
8.2.2 Non-sterile package
The package shall be clearly marked with the following:
a) the name of trademark of the manufacturer or supplier;
b) the material used;
c) the words "TEXTURED", or "SMOOTH", "PRE-POWDERED" or "POWDER-FREE" or words to that effect

for the appropriate glove finish;
d) the size;
e) the manufacturer's identifying lot number;
f) the words "FOR SINGLE USE" or words to that effect;
g) the words "NON-STERILE";
h) the words "EXAMINATION GLOVE" (or “EXAMINATION GLOVES”) or "EXAM GLOVE" (or “EXAM
GLOVES”);
i) the words "DATE OF MANUFACTURE" or words to that effect, and year in four digits and month of
manufacture;
j) the words "Product contains plasticizers (the nature of the plasticizers shall be disclosed) that may be
harmful to users".

ISO 11193-2:2006(E)
8.3 Multi-unit package
A multi-unit package is one containing a predetermined number of gloves (in unit packs or unpackaged) of the
same glove size, intended to facilitate safe transport and storage. Multi-unit packages shall be marked in
accordance with 8.2.1 or 8.2.2, with the approximate number of gloves and with the addition of instructions for
storage.
Key
l length
w width
Figure 1 — Measurement points for width and length

ISO 11193-2:2006(E)
Dimensions in millimetres
NOTE The distance 48 mm ± 9 mm locates the approximate centre of the palm for different glove sizes.
Figure 2 — Measurement points for thickness

ISO 11193-2:2006(E)
Annex A
(normative)
Test for watertightness
A.1 Apparatus
A.1.1 Circular hollow mandrel, of minimum external diameter 60 mm and adequate length to hold the
glove and with the glove attached, to accommodate 1 000 cm3 of water. An example is given in Figure A.1.
NOTE A transparent circular hollow mandrel would be advantageous.
A.1.2 Holding device, deigned to hold the glove in the vertical position filled with water. An example is
given in Figure A.2.
A.1.3 Graduated cylinder, of capacity at least 1 000 cm3, or other dispensing apparatus capable of
delivering 1 000 cm3 at a time.
A.2 Procedure
Attach the glove to the circular hollow mandrel by a suitable device, e.g. an O-ring, so that the glove does not
extend more than 40 mm over the mandrel.
Introduce 1 000 cm3 ± 50 cm3 of water, at a maximum temperature of 36 °C, into the device. Remove water
that has inadvertently splashed onto the glove. If the water does not rise to within 40 mm of the cuff end, the
glove should be raised to ensure that the whole of the glove, excluding the part 40 mm from the cuff end, is
tested. Note any leaks that are immediately evident. If the glove does not leak immediately, make a second
observation for leaks 2 min to 4 min after pouring water into the glove. Disregard leakage within 40 mm of the
cuff end. To assist observation, the water may be coloured with a water-soluble dye.

3
2
1
Key
hook
cylinder
© ISO 2006 – All rights reserved

scoreline on inside surface of wall
Figure A.1 — Mandrel

ISO 11193-2:2006(E)
Dimensions in millimetres
9
10
ISO 11193-2:2006(E)
Figure A.2 — Holding device

Price based on 10 pages

ISO 11193-2:2006(E)

ICS 11.140; 83.140.99
KENYA BUREAU OF STANDARDS (KEBS)
KEBS is mandated to provide Standardization,
KEBS CERTIFICATION MARKS Metrology and Conformity Assessment Services
through:
1. Product Certification Marks • Promotion of standardization in commerce and industry
• Provision of testing and calibration facilities
KEBS Standardization Mark (S-Mark) is issued
for use on products that comply with the minimum

quality requirements prescribed in Kenya
• Control of the use of standardization marks
standards. It uses standards as a benchmark for
quality compliance and aims at giving
• Undertaking educational work in standardization
manufacturers improved market access and also
giving consumers an assurance of quality for the
• Facilitation of the implementation and practical application of standards
products bearing the mark.
• Maintenance and dissemination of the International System of
Units (SI) of measurements
Standardization Mark
SYMBOL FOR PRODUCT QUALITY
KEBS offers the following services:
• Standards development and harmonization
• Testing services
• Measurement services (Calibration)
• Enforcement of standards
• Product inspection services
Diamond Mark of Quality Import Standardization Mark • Education and Training in Standardization, Metrology and Conformity Assessment
SYMBOL FOR PRODUCT QUALITY EXCELLENCE SYMBOL FOR PRODUCT QUALITY • Product and Management Systems Certification Services
2. Systems Certification Marks

INFORMATION ON STANDARDS
Standards are documents that provide a common reference point for the assess-
ment of the quality of goods and services. Standards facilitate tranparency in the
exchange of products and enhance market access of Kenyan products into local,
regional and international markets.
Information on standards and related documents is available at the KEBS stan-
ISO 9001 REGISTERED FIRM OCCUPATIONAL HEALTH AND SAFETY dards information centre.
QUALITY MANAGEMENT SYSTEM OHSAS 18001
KEBS houses the WTO-TBT National Enquiry Point (NEP) which disseminates
notification likely to affect international trade to the industry.
KEBS also provides technical advice on installation and improvement of quality
goods and services to the industry so as to facilitate efficient implementation of
standards. Some of the advantages of standards include: enhancement of quality
assurance, safety and environmental protection measures, minimization of wast-
age, reduction of costs and unecessary varieties and promotion of interchange-
ISO 14001 REGISTERED FIRM ISO 22000 REGISTERED FIRM ability and increased productivity in industry.
ENVIRONMENTAL MANAGEMENT SYSTEM FOOD & SAFETY MANAGEMENT SYSTEM
For further Information please contact
The Managing Director Tel.: +254 (0) 20 6948000

Kenya Bureau of Standards Fax: +254 (0) 20 604031
Popo Road, Off Mombasa Road E-Mail: info@kebs.org
P.O. Box 54794 - 00200 E-Mail: customercare@kebs.org
NAIROBI, KENYA Website: http://www.kebs.org

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Licensed by KEBS. Limited Access during COVID-19 Emergency.

Personal use only

Specification for gloves made from poly(vinyl

First Edition 2008

TECHNICAL COMMITTEE REPRESENTATION

The following organizations were represented on the Technical Committee:

Government Chemists Department

REVISION OF KENYA STANDARDS

© Kenya Bureau of Standards, 2008

ii © KEBS 2008 — All rights reserved

Single-use medical examination gloves —

Specification for gloves made from poly(vinyl

KENYA BUREAU OF STANDARDS (KEBS)

Coast Region Lake Region Rift Valley Region

© KEBS 2008 — All rights reserved iii

iv © KEBS 2008 — All rights reserved

Single-use medical examination gloves —

Specification for gloves made from

Partie 2: Spécifications pour gants fabriqués en chlorure de polyvinyle

ii © ISO 2006 – All rights reserved

© ISO 2006 – All rights reserved iii

International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

SC 4, Products (other than hoses).

— Part 2: Specification for gloves made from poly(vinyl chloride)

iv © ISO 2006 – All rights reserved

Single-use medical examination gloves —

handling contaminated medical materials.

ISO 37:2005, Rubber, vulcanized or thermoplastic — Determination of tensile stress-strain properties

ISO 10993 (all parts), Biological evaluation of medical devices

© ISO 2006 – All rights reserved 1

a) textured surface over part or all of the glove;

5 Sampling and selection of test pieces

Table 1 — Inspection levels and AQLs

Characteristic Inspection level AQL

Physical dimensions (width, length, thickness) S-2 4,0

5.2 Selection of test pieces

2 © ISO 2006 – All rights reserved

0,11 mm, respectively.

Table 2 — Dimensions and tolerances

Size Width Width Width by Minimum Minimum thickness Maximum thickness

© ISO 2006 – All rights reserved 3

6.3 Tensile properties

6.3.2 Force at break and elongation at break before accelerated ageing

inspection level and AQL given in Table 1.

6.3.3 Force at break and elongation at break after accelerated ageing

Tensile tests are then conducted as described in 6.3.2.

Table 3 — Tensile properties

Minimum force at break before accelerated ageing, N 7,0

4 © ISO 2006 – All rights reserved

8.2 Unit package

8.2.1 Sterile package

a) the name or trademark of the manufacturer or supplier;

b) the material used;

c) the words "TEXTURED" or "SMOOTH", "PRE-POWDERED" or "POWDER-FREE", or words to that effect

for the appropriate glove finish;

f) the manufacturer's identifying lot number;

h) the words "STERILE UNLESS THIS PACKAGE IS OPENED OR DAMAGED";

i) the words "FOR SINGLE USE" or words to that effect;

8.2.2 Non-sterile package

The package shall be clearly marked with the following: