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MATERIAL SAFETY DATA SHEET: MEDFLEX PREMIUM LATEX POWDERED GLOVES

January 8, 1998

 

Dentexx Gloves
PO Box 49
Piedmont, SD 57769

www.dentexxgloves.com
FDA# 510K922495		 Emergency phone
1-800-535-5053
Medical Establishment# 1051200
Owner/Operator# 90017-72
FDA# 510K922495



 

IDENTIFICATION FOR MEDFLEX POWDERED LATEX EXAM GLOVES


 

  • ISO 9002 REGISTRATION#: AR 0369
  • PRODUCT NAME: LATEX EXAMINATION GLOVES
  • RAW MATERIAL: NATURAL LATEX (BIODEGRADABLE)


 

CHEMICAL COMPOSITION FOR MEDFLEX POWDERED LATEX EXAM GLOVES


 

  • ALL THE CHEMICALS USED ARE NON-TOXIC/NON-HAZARDOUS:
    • ZINC DIETHYL DITHIOCARBAMATE, ZINC DIBUTHYL DITHIOCARBAMATE, POTASSIUM HYDROXIDE, BUTYLATED REACTION PRODUCT OF P-CRESOL AND DICYCLOPENTADIENE (ANTIOXIDANT), SULPHUR, ZINC OXIDE, TITANIUM DIOXIDE.


 

PHYSICAL DATA FOR MEDFLEX 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 MEDFLEX POWDERED 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 MEDFLEX POWDERED LATEX EXAM GLOVES


 

  • CONFORMITY: The latex examination gloves are produced complies with FDA's "GOOD MANUFACTURING PRACTICE" and ml water tight test.
     
  • AQL Level less than 1.5


 

SPECIAL PROTECTION INFORMATION FOR MEDFLEX POWDERED 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 PRECAUTION FOR MEDFLEX POWDERED LATEX EXAM GLOVES


 

  • To enjoy longer shelf life, caution to be taken in handling and storage: Avoid from 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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