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 |