BIOGREEN™ Biodegradable Nitrile Powder Free Glove

One of Top Glove's ESG initiatives in creating a sustainable world. It provides an "end of life solution" to landfills by reducing the accumulation of waste. Specially formulated to biodegrade in biologically active landfills through a microbial process. Proudly giving businesses more options with an additional feature of Accelerator Free to minimise the risk of Type IV Delayed Hypersensitivity reaction. This is the most popular and reliable glove for medical, healthcare and dental industries. This glove is a reliable protection to avoid cross contamination between food and caterers. A dependable protection for tougher jobs including laboratory work, cleaning, maintenance and general applications. Made of premium compounded nitrile eliminating latex allergy concern. It comes with excellent fit, comfort, sensitivity and protection. Its textured surface helps to provide secure grip and added handling precision.

Colour

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Product Specification

  • Material 

    Synthetic Nitrile Latex

  • Type

    Powder Free, Non-Sterile

  • Colour 

    Pastel Green, White, Tropical Green

  • Flavour (If applicable)

    N/A

  • Design & Features

    Finger Textured, Ambidextrous, Beaded Cuff, Online Single Chlorinated

  • Storage

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

  • Shelf Life

    5 years from the date of manufacturing

  • Application

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

Quality Performance

Functional Benefits

  • Specially formulated to biodegrade in biologically active landfills through a microbial process.
  • An additional feature of Accelerator Free is available, to minimize the risk of Type IV delayed hypersensitivity reaction.
  • A good barrier protection against bacteria, viruses, chemicals, and dangerous substances.
  • Reliable protection to avoid cross-contamination between foods, as well as between caterers and foods.
  • Dependable protection for tougher jobs for laboratory, cleaning, maintenance, and general applications.
  • Free from latex protein, eliminating Type I immediate hypersensitivity reaction.
  • Custom design enhanced comfort and fit.
  • Finger textured enhanced wet and dry grip with added handling precision.
  • Chlorinated powder free interior promotes a smooth donning & doffing experience.

 

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 D6319, EN455 Standards
  • Conforms to Federal Legislation FDA 21 CFR 177.2600
  • Conforms to EU Food Regulation 1935/2004 & EU No.10/2011
  • Complies to PPE Regulation (EU) 2016/425 requirements
  • Tested for biodegradability according to ASTM D5511 under defined conditions to determine anaerobic biodegradation.

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 
  • 300 ± 10
  • 76 ± 3
  • 84 ± 3
  • 94 ± 3
  • 105 ± 3
  • 113 ± 3
  • Finger : Min 0.05 (≥ 2.0 Mil)
  • Palm : Min 0.05 (≥ 2.0 Mil)
 

ASTM D6319

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
  • 110 ± 10
  • 120 ± 10
  • Finger: Min 0.05 (≥ 2.0 Mil)
  • Palm :  Min 0.05 (≥ 2.0 Mil)

Elongation at Break, %

  • Before Aging
     
    Min 500
  • After Aging
     
    Min 400

Tensile Strength, MPa

  • Before Aging
     
    Min 14
  • 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 500
  • After Aging
     
    Min 400

Median Force at Break, N

  • Before Aging
     
    Min 7
  • After Aging
     
    Min 6
 

Product Safety Conformance

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.

ACCELERATOR FREE TESTED Pass

Reference: ASTM D7558-09 Standard Test Method for Colorimetric / Spectrophotometric Procedure to Quantify Extractable Chemical Dialkldithiocarbamate,Thiuram and Mercaptobenzothiazole Accelerators in Natural Rubber Latex and Nitrile Glove

Purpose:  To ensure the gloves are not containing residual of chemical additives at the level that may include Type IV allergy in the un-sensitized general user population.

Test items Test Results
Total Thiol Vulcanization Accelerator µg/g µg/dm2
Not Detected Not Detected

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

BIODEGRADABILITY TESTED Pass

Reference: ASTM D5511 Standard Test Method for Determining Anaerobic Biodegradation of Plastic Materials Under High-Solids Anaerobic-Digestion Conditions.

Purpose: To confirm biodegradability of the gloves under anaerobic condition.

Biodegradable % at (513 days) Test Results
36.7

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

Chemical Residue Tested Pass

Purpose: To ensure gloves are free from any chemical substances.

Chemical Test (s) Test Results (μg/g)
Butylated Hydroxyanisole (BHA) Not Detected
Butylated Hydroxytoluene (BHT) Not Detected
Diphenyl Thiourea (DPTU) Not Detected
Zinc Mercaptobenzothiazole (ZMBT) / (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 Pentamethyleneditithiocarbamate (ZPMC) Not Detected

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

Product Information for Food Contact (EU Food Regulation 1935/2004 and EU No. 10/2011) Pass

 Standard Property External Lab Test Results Artwork Labelling
EU Food Regulation 1935/2004 and EU No. 10/2011 Overall Migration Simulant Overall Migration
10% Ethanol PASS
20% Ethanol PASS
50% Ethanol PASS
3% Acetic Acid PASS
Olive Oil PASS
Test Condition :  40°C, 2 hours This product is suitable for food handling, (tested for 2 hours at 40°C, EU No. 10/2011)
Standard :  <10 mg/dm2 for all Simulants
Federal Legislation CFR US FDA 21 CFR 177.1520 Overall Migration Simulant
 Overall Migration
Total Extractives
Density PASS
Maximum Extractable Fraction PASS
n-hexane
Maximum Soluble PASS This product is suitable for food handling under US FDA 21 CFR 175.300
Xylene

 

Product Information for Food Contact FDA 21 CFR 177.2600“Rubber Articles Intended for Repeated Use” Pass

Purpose: To determine total extractable per FDA 21 CFR 177.2600 and to ensure no chemical substances migrating from the food contact material to the food.

 Standard Property External Lab Test Results Artwork Labelling

Federal Legislation CFR US FDA 21 CFR 177.2600

 Overall Migration Simulant
 Overall Migration
  
Distilled water at reflux temperature for 7 hours
 PASS
Distilled water at reflux temperature for succeeding 2 hours  PASS
n-Heptane at reflux temperature for 7 hours PASS
n-Heptane at reflux temperature for succeeding 2 hours PASS
 This product is suitable for food handling under US FDA 21 CFR 177.2600

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

Product Information for Food Contact (Japan’s Specifications and Standards for Food Additives under Food Sanitation Act) JETRO Test Pass

Purpose: To determine the amount of substances that is transported from the sample into a leaching solution

Standard Property External Lab Test Result
Japan's Specifications and Standards for Food Additives under Food Sanitation Act Overall Migration Evaporation Residue Content using 20% Ethanol Test Results  (µg/ml)
PASSES

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

Product Information for Food Contact According to BfR Recommendation XXI with reference to EN1186-9:2002-Test Methods for overall migration into aqueous food simulants by article filling Pass

Purpose:  To determine total global migration extractable as per BfR Recommendation XXI and to ensure no chemical substances migrating from the food contact material to the food

Standard Property External Lab Test Results
BfR Recommendation XXI with reference to EN1186-9:2002 Overall Migration Stimulant Test Result (mg/dm2)
DI Water PASSES
3% Acetic Acid PASSES
10% Ethanol PASSES

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

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