SUPERMAX "Making World Class Medical Gloves of the Finest Quality"
















Lot 38, Putra Industrial Park,
Bukit Rahman Putra,
47000 Sungai Buloh,
Selangor Darul Ehsan, Malaysia
Tel: 603-6145 2328
 
ISO 9001:2000 SIRIM, Malaysia (1996, 2001)
Special Regulation NF101 AFNOR, LNE, France (1996)
ISO 9001:2000 RWTUV, Germany (1996, 1999, 2001)
ISO 9001:2000 BVQI (1999, 2001)
CE Mark on Sterilised Latex Gloves audited by SGS,
   UK and SGS, Malaysia (1999)
ISO 13488:1996 audited by Standard Council of Canada,
   accredited registrar, SGS Canada (2004)


FDA 510k registration
   #k915251 with US FDA on Low Powder Hypoallergenic Latex Examination Gloves
FDA 510k registration
   #k980071 with US FDA on Powder Free Latex Examination Gloves with
     Protein Content Labeling Claim (50 mgs or less)
FDA 510k registration
   #k980494 with US FDA on Latex Powdered Exam Gloves with 70 mgs or
     Less Total Water Extractable Protein Per Gram.
FDA 510k registration
   #k991415 with US FDA on Polymer Coated Powder Free Latex Examination Gloves
     (50 mgs or less protein labeling claim)
FDA 510k registration
   #k980966 with US FDA on Powdered Nitrile Examination Gloves
FDA 510k registration
   #k013953 with US FDA on Aurelia Chlorinated Powder Free Latex Medical Examination      gloves with Aloe Vera & Ginseng with Protein Labeling Claim (50 mgs or less)
FDA 510k registration
   #k993258 with US FDA on Powder Free Nitrile Examination Gloves
FDA 510k registration
   # k993865 with US FDA on Green Peppermint Flavored Powdered Latex
      Examination Gloves
FDA 510k registration
   #k993864 with US FDA on Green Peppermint Flavored Powder Free Latex Examination      Gloves with Protein Content Labeling Claim (50 mgs or less)
FDA 510k registration
   #k000644 with US FDA on Sterile Powdered Latex Examination Gloves
FDA510k registration
   #k010198 with US FDA on Sterile Powdered Latex Surgeon Gloves
FDA 510k registration
   #k014230 with US FDA on Sterile Powder Free Latex Surgeon gloves with
     Protein Labeling claim (50 mgs or less)
FDA 510k registration
   #k024083 with US FDA on Green Powder Free Nitrile Medical Examination Gloves with      Peppermint Flavour.


Certificate of Listing from Canadian General Standards Board (CGSB), Canada
Certificate of Listing No: AUST L 63625 from TGA, Australia
Certification from American Dental Association (ADA)
Standard Malaysian Glove Certificate of Accreditation from Malaysian Rubber Board
Directive 93/42/EEC Annex V (Sterility only) – Sterile Gloves from SGS, UK
Directive 89/686/EEC Article 11B-PPE from SGS, UK


Watertightness : ASTM D5151:99
Physical Properties
   1) Dimension : ASTM D3767:01
   2) Tensile : ASTM D412:98 & ASTM D573:99
Protein Testing : ASTM D5712:99
Residual Powder Testing : ASTM D6124:01
Biocompatibility Testing
   *Samples sent to CPTC, USA for testing
Bioburden Testing
   *Samples sent to microbiological lab for testing


 
   
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