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MATERIAL SAFETY DATA SHEET: DENTEXX SYNTHETIC POWDERED EXAM GLOVE
JANUARY 15, 2001
Dentexx Gloves
PO Box 49
Piedmont, SD 57769
www.dentexxgloves.com |
FDA 510k #
K993664 |
IDENTIFICATION
- PRODUCT NAME: Synthetic Clear Powdered Examination Gloves
- TRADE NAME: Dentexx Synthetic Powdered Examination Gloves
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CHEMICAL COMPOSITION
- All the chemicals used are non-toxic and non-hazardous:
- Polyvinyl Chloride resin, Di-2-Ethyhexyl Phthalate,
Di-2-Ethylhexyl Adipate, 2, 2, 4-Trimethyl-1, 3-Pentanediol,
Calcium-zinc Sterates, Epoxidized Soyabean oil, cornstarch and
Blue/green Pigment.
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PHYSICAL DATA
| DIMENSION |
X-LARGE |
LARGE |
MEDIUM |
SMALL |
X-SMALL |
| LENGTH (mm) |
MIN 230 (same for all sizes) |
| WIDTH (mm) |
115 +/-5 |
106 +/-5 |
95 +/-5 |
85 +/-5 |
75 +/-5 |
| TENSILE PROPERTIES |
UNAGED |
AGED |
| TENSILE STRENGTH (MPa) |
MIN 21 MPa |
MIN 16 MPa |
| ULTIMATE ELONGATION (%) |
MIN 700% |
MIN 500% |
| MODULUS AT 300% ELONGATION |
MIN 1.0 MPa |
MIN 0.8 MPa |
HEALTH HAZARD DATA
- BIOCOMPATABILITY: The chemical formulation of the gloves and
surface lubrication materials do not contain any substances normally
known to be harmful to the user or to any person with whom the
gloves come into contact.
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QUALITY ASSURANCE CONFORMITY
- CONFORMITY: The gloves comply with FDA "GOOD MANUFACTURING
PRACTICE" and ml water tight test.
- AQL Level less than 1.5
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SPECIAL PRECAUTIONS
- To enjoy longer shelf life, caution should be taken in handling
and storage. Avoid direct sunlight. Keep in cool, dry place. Gloves
are easily contaminated while in contact with copper content
materials, organic-Clair-solvent and animal fats.
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