PATIENT LATEX EXAMINATION POWDER-FREE POLYMER COATED GLOVES

Latex Patient Examination Glove

WEAR SAFE MALAYSIA SDN. BHD.

The following data is part of a premarket notification filed by Wear Safe Malaysia Sdn. Bhd. with the FDA for Patient Latex Examination Powder-free Polymer Coated Gloves.

Pre-market Notification Details

Device IDK992676
510k NumberK992676
Device Name:PATIENT LATEX EXAMINATION POWDER-FREE POLYMER COATED GLOVES
ClassificationLatex Patient Examination Glove
Applicant WEAR SAFE MALAYSIA SDN. BHD. LOT 1, LEBOH HISHAMUDDIN SATU, NORTH KLANG STRAITS IND. AREA Port Klang, Selangor, D.e.,  MY 42000
ContactClaude Cottet
CorrespondentClaude Cottet
WEAR SAFE MALAYSIA SDN. BHD. LOT 1, LEBOH HISHAMUDDIN SATU, NORTH KLANG STRAITS IND. AREA Port Klang, Selangor, D.e.,  MY 42000
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-08-10
Decision Date1999-12-16

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