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    POLYCARE Brochure

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    bombmaker92
    This document provides information on Polycare Latex Examination Gloves that are powder-free and made of natural rubber latex. The gloves are intended to protect both patients and healthcare workers from contamination during examinations or procedures. They meet various quality and regulatory standards including ASTM D3578 and EN 455 for physical properties like tensile strength and elongation. The gloves are available in different sizes from extra small to extra large.

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    © All Rights Reserved
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    POLYCARE Brochure

    Uploaded by

    bombmaker92
    63 views3 pages
    This document provides information on Polycare Latex Examination Gloves that are powder-free and made of natural rubber latex. The gloves are intended to protect both patients and healthcare workers from contamination during examinations or procedures. They meet various quality and regulatory standards including ASTM D3578 and EN 455 for physical properties like tensile strength and elongation. The gloves are available in different sizes from extra small to extra large.

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    POLYCARE Brochure

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    This document provides information on Polycare Latex Examination Gloves that are powder-free and made of natural rubber latex. The gloves are intended to protect both patients and healthcare workers from contamination during examinations or procedures. They meet various quality and regulatory standards including ASTM D3578 and EN 455 for physical properties like tensile strength and elongation. The gloves are available in different sizes from extra small to extra large.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    63 views3 pages

    POLYCARE Brochure

    Uploaded by

    bombmaker92
    This document provides information on Polycare Latex Examination Gloves that are powder-free and made of natural rubber latex. The gloves are intended to protect both patients and healthcare workers from contamination during examinations or procedures. They meet various quality and regulatory standards including ASTM D3578 and EN 455 for physical properties like tensile strength and elongation. The gloves are available in different sizes from extra small to extra large.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 3

    POLYCARE LATEX EXAMINATION GLOVES, POWDER-FREE

    DESCRIPTION

    Examination glove is a non-sterile, disposable medical device, made of Natural Rubber Latex
    and is worn on the hand of a health care professional. The device is used mainly as a two-
    way barrier to protect both the patient and the staff against various contamination. It will
    have appropriate characteristics regarding tactility/comfort of use, and should provide
    appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions.

    PRODUCT DESCRIPTION

    Type: Powder-Free and non-sterile examination

    Material: Natural Rubber Latex

    Design: Beaded cuff, Powder-Free, Ambidextrous and coated with polymer coated.

    Colour: Off white to light yellow.

    Size: XS, S, M, L, XL

    PHYSICAL PROPERTIES

    PROPERTIES ASTM D3577 EN455


    Force at Break (N)
     Unaged N/A Median ≥6
     Aged Median ≥6
    Tensile Strength (MPa)
     Unaged Min. 18 N/A
     Aged Min. 14
    Elongation at Break (%)
     Unaged Min. 650 N/A
     Aged Min. 500
    Modulus 500% (MPa)
     Unaged Max. 5.5 N/A
     Aged -
    PHYSICAL DIMENSION

    Length (mm) All sizes : ≥240


    Palm Witdh (mm) ≤ 80 (Size XS)
    80±10 (Size S)
    95±10 (Size M)
    110±10 (Size L)
    ≥110 (Size XL)
    Thickness (mm)
     Finger ≥0.08
     Palm ≥0.08
     Compliance to EN 455 & ASTM 3578

    QUALITY STANDARD

    1. Manufactured under EN ISO 13485:2016 (Quality Management System)


    2. Comforms to ASTM D3578
    3. EN 455 Part 1, 2, 3, 4
    4. EN ISO 374 Part 1, 2, 3, 4
    5. EN ISO 21420:2020

    REGULATORY COMLIANCE

     US FDA 510(K) (Class I)


     Medical Device: in compliance with European Medical Device Regulation 2017/745
    (CE Class I)
     Personal Protective Equipment Regulation (EU) 2016/425 (Category III)

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