BIOGREEN™ FSC™ CERTIFIED 认证乳胶有粉手套

Our FSC™ Certified Latex Glove qualify as an eco-friendly product which the gloves are manufactured in a responsible environmental, social and economic practices with FSC certified material used. An all-rounder glove that is suitable for use in medical healthcare and dental procedures as well as a wide variety of low to moderate risk general applications. The evenly distributed lightly powdered at the donning side makes this glove so easy to don and is effective for perspiration absorption which provide comfortable and dry feel.

  • European Countries: Class I EU MDR 2017/745
  • United States of America (USA): Class I

Colour

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Product Specification

  • Material

    Natural High Grade Rubber Latex

  • Type

    Powdered, Non-Sterile

  • Design & Features

    Smooth or Palm Textured Surface, Ambidextrous, Beaded cuff, USP Grade Absorbable Corn Starch

  • Colour

    Natural

  • Flavour

    N/A

  • Shelf-life

    5 years from the date of manufacturing

  • Storage

    The gloves shall maintain their properties when stored in a dry condition. Avoid direct sunlight

  • Application

    Medical, Healthcare, Dental, General Lab Work, Cleaning & Maintenance Purpose, General Use

Quality Performance

Functional Benefits

  • Eco-friendly with conformity according to FSC CoC (STD-40-004)
  • A good barrier protection against bacteria and viruses
  • Superior dexterity with good fit & tactile sensitivity
  • Latex softness provide comfortability for extended use
  • Lightly powdered interior promote easy donning and doffing and is effective for perspiration absorption

Glove Sizes

  • XS
  • S
  • M
  • L
  • XL

Quality Standards

  • Manufactured under QSR (GMP), ISO 9001:2015 and ISO 13485:2016 Quality Management System
  • Conforms to ASTM D3578, EN455, ISO 11193 Standards

 

 

Physical Dimension & Physical Properties

TOP GLOVE

Size Length (mm) Palm width (mm) Thickness : Single wall (mm)
  • XS
  • S
  • M
  • L
  • XL
  • Min 230, Min 240
  • (All sizes)
  • 76 ± 3
  • 84 ± 3
  • 94 ± 3
  • 105 ± 3
  • 113 ± 3
  • Finger : Min 0.08 (≥ 3.2 Mil)
  • Palm : Min 0.08 (≥ 3.2 Mil)
 

ASTM D3578

Size Length (mm) Palm width (mm) Thickness : Single wall (mm)
  • XS
  • S
  • M
  • L
  • XL
  • Min 220 (XS, S)
  • Min 230 (M, L, XL)
  • 70 ± 10
  • 80 ± 10
  • 95 ± 10
  • 111 ± 10
  • 120 ± 10
  • Finger: Min 0.08 (≥ 3.2 Mil)
  • Palm :  Min 0.08 (≥ 3.2 Mil)

Elongation at Break, %

  • Before Aging
     
    Min 650
  • After Aging
     
    Min 500

Tensile Strength, MPa

  • Before Aging
     
    Min 18
  • After Aging
     
    Min 14

EN 455 

Size Length (mm) Palm width (mm) Thickness : Single wall (mm)
  • XS
  • S
  • M
  • L
  • XL
  • Min 240
  • ≤80
  • 80 ± 10
  • 95 ± 10
  • 110 ± 10
  • ≥110
  • N/A

Median Force at Break, N 

  • Before Aging
     
    Min 6
  • After Aging
     
    Min 6
 

ISO 11193

Size Length (mm) Palm width (mm) Thickness : Single wall (mm)
  • XS
  • S
  • M
  • L
  • XL
  • Min 220 (XS, S)
  • Min 230 (M, L, XL)
  • ≤80
  • 80 ± 10
  • 95 ± 10
  • 110 ± 10
  • ≥110
  • Smooth : Min 0.08 (≥ 3.2 Mil)
  • Textured : Min 0.11 (≥ 4.4 Mil)

Elongation at Break, %

  • Before Aging
     
    Min 650
  • After Aging
     
    Min 500

Median Force at Break, N

  • Before Aging
     
    Min 7
  • After Aging
     
    Min 6
 

Product Safety Conformance

CHEMICAL RESIDUE TESTED Pass

Purpose: To ensure the gloves are free from any chemical substances and safe to use.

Chemical Test (s) Test Results (μg/g)
Butylated Hydroxyanisole (BHA) Not Detected
Butylated Hydroxytoluene (BHT) Not Detected
Diphenyl Guanidine (DPG) Not Detected
Diphenyl Thiourea (DPT) Not Detected
Mercaptobenzothiazole (MBT) Not Detected
Tetramethylthiuram Disulphide (TMTD) Not Detected
Zinc Dibutyldithiocarbamate (ZDBC) Not Detected
Zinc Diethyldithiocarbamate (ZDEC) Not Detected
Zinc Dimethyldithiocarbamate (ZDMC) Not Detected
Zinc Mercaptobenzimidazole (ZMBI) Not Detected
Zinc Mercaptobenzothiazole (ZMBT) Not Detected
Zinc Pentamethyleneditithiocarbamate (ZPMC) Not Detected

Remark: Applicable to selected product. Please liaise with our representative for further details.

VIRAL PENETRATION TESTED Pass

Reference: ASTM F1671 - Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood - Borne Pathogens Using Phl-X 174 Bacteriophage Penetration as a Test System

Purpose: To test the barrier protection of the gloves from the passages of the viruses.

Viral Penetration Test Results
PASSES

Remark: Applicable to selected products. Please liaise with our representative for further details.

BIOCOMPATIBILITY TESTED Pass

Reference: ISO 10993-10 (Test for Skin Irritation and Skin Sensitization)

Purpose: Biological evaluation for medical devices for irritation and delayed type hypersensitivity.

Biocompatibility Test Test Results
Primary Skin Irritation

PASSES

Not a primary skin irritant under condition of the study
Skin Sensitization

PASSES

Not a contact sensitizer under condition of the study

Remark: Applicable to selected product. Please liaise with our representative for further details.

HEAVY METAL TESTED Pass

Reference: EPA Method 3052

Purpose: To ensure the gloves are free from heavy metal substances and safe to use.

Chemical Test (s) Test Results (μg/g)
Cadmium (Cd) Not Detected
Lead (Pb) Not Detected
Mercury (Hg) Not Detected
Arsenic (As) Not Detected
Antimony (Sb) Not Detected
Tin (Sm) Not Detected

Remark: Applicable to selected product. Please liaise with our representative for further details.

PHTHALATES TESTED Pass

Purpose: Compliance on REACH Regulation (EC) 1907/2006 Annex XVII requirements for phthalates

Chemical Test (s) Test Results (μg/g)
Dibutyl Phthalate (DBP) Not Detected
Di(2-ethylhexyl) Phthalate (DEHP) Not Detected
Di-n-octyl Phthalate (DNOP) Not Detected
Di-isononyl Phthalate (DINP) Not Detected
Di-isodecyl Phthalate (DIDP) Not Detected
Benzyl butyl Phthalate (BBP) Not Detected

 

Remark: Applicable to selected product. Please liaise with our representative for further details.

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