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MATERIAL SAFETY DATA SHEET: DENTEXX POWDER FREE
NOVEMBER 22, 2000
Dentexx
PO Box 49
Piedmont, SD 57769
www.dentexxgloves.com |
FDA 510k #
K990690 |
IDENTIFICATION
- PRODUCT NAME: Copolymer Powder Free Latex Exam Gloves
- TRADE NAME: Dentexx Copolymer Powder Free
- PROTEIN LEVEL:Less than 50 micrograms extractable latex protein
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CHEMICAL COMPOSITION
- All the chemicals used are non-toxic and non-hazardous:
- Natural Rubber Latex, Sulphur, Zinc Oxide, ZDBC, Titanium
Dioxide, Calcium Nitrate, Calcium Carbonate Antioxidant and Corn
Starch.
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PHYSICAL DATA
| DIMENSION |
X-LARGE |
LARGE |
MEDIUM |
SMALL |
X-SMALL |
| LENGTH (mm) |
MIN 240 (same for all sizes) |
| WIDTH (mm) |
113 +/-3 |
105 +/-3 |
94 +/-3 |
84 +/-3 |
76 +/-3 |
| THICKNESS FINGER (mm) |
0.16+/-0.03
ALL SIZES |
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THICKNESS
PALM (mm) |
0.15+/-0.03
ALL SIZES |
| TENSILE PROPERTIES |
UNAGED |
AGED |
| TENSILE STRENGTH (MPa) |
MIN 21 MPa |
MIN 16 MPa |
| ULTIMATE ELONGATION (%) |
MIN 700% |
MIN 500% |
| MODULUS AT 500% ELONGATION |
MIN 5.5 MPa |
MIN 2.8 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 less than 1.5
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SPECIAL PROTECTION INFORMATION
- Special design formulation and techniques applied to have low
protein content mean safer to sensitive skin.
- Latex examination gloves can be used in handling certain chemicals
e.g. ALCOHOL, AMMONIUM HYDROXIDE, CITRIC ACID, EPOXY RESIN,
INORGANIC SALT, LACTIC ACID, GLYCERINE, ETC.
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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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