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.
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.
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 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 |
---|