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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 K934133
Device Name PATIENT EXAMINATION GLOVES (POWDER FREE GLOVES)
Applicant
Supergrade Healthcare Products Sdn. Bhd.
41, Amoy Ln.,
10050 Penang, Malaysia,  ML
Applicant Contact OOI BOON SENG
Correspondent
Supergrade Healthcare Products Sdn. Bhd.
41, Amoy Ln.,
10050 Penang, Malaysia,  ML
Correspondent Contact OOI BOON SENG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/18/1993
Decision Date 01/07/1994
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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