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MATERIAL SAFETY DATA SHEET: DENTEXX  POWDER FREE LATEX EXAM GLOVE

NOVEMBER 22, 2000

 

Dentexx 
PO Box 49
Piedmont, SD 57769 

www.dentexxgloves.com		 FDA 510k # K990690


 

IDENTIFICATION FOR DENTEXX POWDER FREE LATEX EXAM GLOVES


 

  • PRODUCT NAME: Copolymer Powder Free Latex Exam Gloves
  • TRADE NAME: Dentexx Copolymer Powder Free
  • PROTEIN LEVEL:Less than 50 micrograms extractable latex protein


CHEMICAL COMPOSITION FOR DENTEXX POWDER FREE LATEX EXAM GLOVES
 

  • 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.


PHYSICAL DATA FOR DENTEXX POWDER FREE 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
THICKNESS FINGER (mm) 0.16+/-0.03
ALL  SIZES 		  
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 FOR DENTEXX POWDER FREE LATEX 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 LATEX EXAM GLOVES

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

SPECIAL PROTECTION INFORMATION FOR DENTEXX POWDER FREE LATEX EXAM GLOVES

  1. Special design formulation and techniques applied to have low protein content mean safer to sensitive skin.
  2. 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.

SPECIAL PRECAUTIONS FOR DENTEXX POWDER FREE LATEX 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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