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 |