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JANUARY 8, 2000
| Dentexx Gloves PO Box 49 Piedmont, SD 57769 www.dentexxgloves.com |
FDA 510k # K913409 |
IDENTIFICATION FOR DENTEXX POWDERED LATEX EXAM GLOVES
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CHEMICAL COMPOSITION
FOR DENTEXX POWDERED LATEX EXAM GLOVES
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PHYSICAL DATA
FOR DENTEXX POWDERED LATEX EXAM GLOVES
| 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 |
| 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
FOR DENTEXX POWDERED LATEX EXAM GLOVES
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QUALITY ASSURANCE CONFORMITY FOR DENTEXX POWDERED LATEX EXAM GLOVES
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SPECIAL PROTECTION INFORMATION FOR DENTEXX POWDERED LATEX EXAM GLOVES
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SPECIAL PRECAUTIONS FOR DENTEXX POWDERED LATEX EXAM GLOVES
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