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)