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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 K062917
Device Name STERILE AND NON-STERILE POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRACTABLE PROTEIN CONTENT LABELING CLAIM (50
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 TK LOH
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 TK LOH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/28/2006
Decision Date 11/02/2006
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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