Description
Examination Glove is a disposable device intended for medical purposes that are worn on the examiner’s hand to prevent contamination between the patient and examiner.
- European Countries: Class I MDD Directive 93/42 / EEC
- United States of America (USA): Class I with approved 21.CFR.820 FDA 510 (K)
FUNCTIONAL BENEFITS:
- Protection from unwanted or dangerous substances
- Easy donning and helps prevent roll back
- Softness provides superior comfort and natural fit
- Beaded cuff makes donning easy
- Ambidextrous and straight fingers
QUALITY STANDARDS:
- Conforms to ASTM D3578 and EN 455 Standards
- Manufactured under QSR (GMP), ISO 9001: 2015 and ISO 13485: 2016 Quality Management System
GLOVE SIZES:
- Small, Medium, Large
PRODUCT SAFETY CONFORMANCE:
1.1) 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 |
1.2) VIRAL PENETRATION TESTED
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
| Viral Penetration | Test Results |
|---|---|
| Passes |
Remarks: Applicable to selected products. Please liaise with our representative for further details.
1.3) HEAVY METAL TESTED
Purpose: To ensure gloves are free from heavy metals substances
| Chemical Test (s) | Test Results (mg/kg) |
|---|---|
| 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.
1.4) CHEMICAL RESIDUE TESTED
Purpose: To ensure gloves are free from any chemical substances
| Chemical Test (s) | Test Results (μg/g) |
|---|---|
| Butylated Hydroxyanisole (BHA) | Not Detected |
| Butylated Hydroxytoluene (BHT) | 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 |
Remarks: Applicable to selected products. Please liaise with our representative for further details.
Brand MUMU is from manufacturer Top Gloves:
Full brochure http://www.cmddental.be/TG_Latex_Glove.pdf
