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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 K892177
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Chem-Specialties Sdn Bhd
Lot 17, Solok Hishamuddin 4
Kaw. 20, N. Klang Straits
Ind.Area, Port Klang Selangor,  MY 42000
Applicant Contact YOKE FOON
Correspondent
Chem-Specialties Sdn Bhd
Lot 17, Solok Hishamuddin 4
Kaw. 20, N. Klang Straits
Ind.Area, Port Klang Selangor,  MY 42000
Correspondent Contact YOKE FOON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/05/1989
Decision Date 08/23/1989
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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