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Quality Test

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

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

Property

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

Purpose: To check the presence of bacterial in gloves after sterilization process

Test

Test Results

Sterility Test

Passes

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

Purpose: To check the presence of bacterial in gloves and it can cause variety of inflammatory responses if enough of their molecules get in the bloodstream

Test

Test Results

Bacterial Endotoxin

Passes

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

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

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

Test

Test Results

Viral Penetration

Passes

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

Purpose: To test the efficiency and safety of glove usage

Test

Test Results

Clinical Evaluation

Passes

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

Purpose: To test the numbers of bacterial living on the glove’s surface that has not been sterilized

Test

Test Results

Bioburden

Passes

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

Purpose: To ensure gloves are free from heavy metals substances

Chemical Test

Test Results

Cadmium (Cd)

Not Detected

Lead (Pb)

Not Detected

Mercury (Hg)

Not Detected

Arsenic (As)

Not Detected

Antimony (Sb)

Not Detected

Tin (Sin)

Not Detected

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

Purpose: To ensure gloves are free from any chemical substances

Chemical Test

Test Results

Butylated Hydroxyanisole (BHA)

Not Detected

Butylated Hydroxytoluene (BHT)

Not Detected

Diphenyl Guanidine (DPG)

Not Detected

Diphenyl Thiourea (DPT)

Not Detected

Mercaptobenzothiazole (ZMBT)

Not Detected

Zinc Mercaptobenzothiazole (ZMBT)

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