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MATERIAL SAFETY DATA SHEET: DENTEXX POWDER FREE VINYL EXAM GLOVE

JANUARY 15, 2001

 

Dentexx Gloves
PO Box 49
Piedmont, SD 57769

www.dentexxgloves.com		 FDA 510k # K993664


 

IDENTIFICATION FOR DENTEXX POWDER FREE VINYL EXAM GLOVES


 

  • PRODUCT NAME: Vinyl Powder Free Examination Gloves
  • TRADE NAME: Dentexx Vinyl Powder Free Exam Gloves

CHEMICAL COMPOSITION FOR DENTEXX POWDER FREE VINYL EXAM GLOVES
 

  • 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, Blue/green Pigment.


PHYSICAL DATA FOR DENTEXX POWDER FREE VINYL EXAM GLOVES  

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 FOR DENTEXX POWDER FREE VINYL EXAM GLOVES   

  • 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.
 

QUALITY ASSURANCE CONFORMITY FOR DENTEXX POWDER FREE VINYL EXAM GLOVES  

  • CONFORMITY: The gloves comply with FDA "GOOD MANUFACTURING PRACTICE" and ml water tight test.
     
  • AQL Level less than 1.5
 

SPECIAL PRECAUTIONS FOR DENTEXX POWDER FREE VINYL EXAM GLOVES  

  • 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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