1) Biocompatibility Tested
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 |
2) Chemical Residue Tested
Purpose: To ensure gloves are free from any chemical substances
Chemical Test |
Test Results (μg/g) |
Butylated Hydroxyanisole (BHA) |
Not Detected |
Butylated Hydroxytoluene (BHT) |
Not Detected |
Diphenyl Thiourea (DPT) |
Not Detected |
Zinc Mercaptobenzothiazole (ZMBT)/(MBT) |
Not Detected |
Tetramethylthiuram Disulphide (TMTD) |
Not Detected |
Zinc Dibutyldithiocarbamate (ZD8C) |
Not Detected |
Zinc Diethyldithiocarbamate (ZDEC) |
Not Detected |
Zinc Dimethyldithiocarbamate (ZDMC) |
Not Detected |
Zinc Mercaptobenzimidazole (ZMBI) |
Not Detected |
Zinc Pentamethyleneditithiocarbamate (ZPMC) |
Not Detected |
3) Nitrosamine Tested
Purpose: To test the carcinogenic potential of chemical substances in condom products
Chemical Test |
Test Results (μg/g) |
N-nitrosodimethylamine (NDMA) |
Not Detected |
N-nitrosodiethylamine (NDEA) |
Not Detected |
N-nitrosodipropylamine (NDPA) |
Not Detected |
N-nitrosodibutylamine (NDBA) |
Not Detected |
N-nitrosopiperidine (NPIP) |
Not Detected |
N-nitrosopyrrolidine (NPYR) |
Not Detected |
N-nitrosomorpholine (NMOR) |
Not Detected |
N-nitrosodibenzylamine (NDBzA) |
Not Detected |
N-nitroso-N-methyl-N-phenylamine (NMPhA) |
Not Detected |
N- nitroso-N-ethyl-N-phenylamine (NEPha) |
Not Detected |
N-nitrososodiisononylamine (NDiNA) |
Not Detected |
4) Bioburden Tested
Purpose: To test the numbers of bacteria living on the condom's surface that has not been sterilized
Bioburden |
Test Results (ng/g) |
Passes |
5) Clinical Evaluation Tested
Purpose: To test efficiency and safety of condom product usage
Clinical Evaluation |
Test Results |
Passes |
6) Acute Systemic Toxicity Tested
Purpose: To evaluate the adverse effect following an intraperitoneal administration of a single, multiple or continuous dose of test material within 24 hours
Acute Systemic Toxicity |
Test Results |
Passes
Not a potential toxic agent under condition of the study |