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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 K922495
Device Name SUPER GLOVES(R) HYPOALLERGENIC
Applicant
Taiping Super Holdings Sdn Bhd
Lot. 1185 Kamunting Ind.Estate
P.O.Box 24
34007 Taiping, Perak.,  TW
Applicant Contact LOW
Correspondent
Taiping Super Holdings Sdn Bhd
Lot. 1185 Kamunting Ind.Estate
P.O.Box 24
34007 Taiping, Perak.,  TW
Correspondent Contact LOW
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/27/1992
Decision Date 09/04/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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