Intro
Details
| Dimension | Standard |
|---|---|
|
Length (mm) |
Min 180 |
|
Palm Width (mm) |
52 ± 2 |
|
Thickness: |
0.07 ± 0.01 |
| Description | Standard |
|---|---|
|
Burst Pressure (kPa) |
Min 1.0 |
|
Burst Volume (L) |
Min 18.0 |
| Description | Standard |
|---|---|
|
Lubricant Quantity |
550±150 |
Purpose: To ensure the gloves are free from any chemical substances and safe to use.
| Chemical Test (s) | Test Results (μg/g) |
|---|---|
| Butylated Hydroxyanisole (BHA) | Not Detected |
| Butylated Hydroxytoluene (BHT) | Not Detected |
| Diphenyl Thiourea (DPT) | Not Detected |
| Mercaptobenzothiazole (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 Mercaptobenzothiazole (ZMBT) | Not Detected |
| Zinc Pentamethyleneditithiocarbamate (ZPMC) | Not Detected |
Remark: Applicable to selected products. Please liaise with our representative for further details.
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.
To test the carcinogenic potential of chemical substances in condom products.
| Chemical Test (s) | 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 |
To test the numbers of bacterial living on the glove’s surface that has not been sterilized.
| Bioburden | Test Result |
|---|---|
| PASSES |
Remark: Applicable to selected products. Please liaise with our representative for further details.
To test the efficiency and safety of glove usage.
| Clinical Evaluation | Test Result |
|---|---|
| PASSES |
Remark: Applicable to selected products. Please liaise with our representative for further details.
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
|
Not a potential toxic agent under condition of the study |
|---|
