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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K062778
Device Name STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED
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 LIM L BUNG
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 LIM L BUNG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/18/2006
Decision Date 10/27/2006
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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