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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K992676
Device Name PATIENT LATEX EXAMINATION POWDER-FREE POLYMER COATED GLOVES
Applicant
WEAR SAFE MALAYSIA SDN. BHD.
LOT 1, LEBOH HISHAMUDDIN SATU,
NORTH KLANG STRAITS IND. AREA
PORT KLANG, SELANGOR, D.E.,  MY 42000
Applicant Contact CLAUDE COTTET
Correspondent
WEAR SAFE MALAYSIA SDN. BHD.
LOT 1, LEBOH HISHAMUDDIN SATU,
NORTH KLANG STRAITS IND. AREA
PORT KLANG, SELANGOR, D.E.,  MY 42000
Correspondent Contact CLAUDE COTTET
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/10/1999
Decision Date 12/16/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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