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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 K992870
Device Name POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES LABELING CONTENT: 100 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEI
Applicant
Alliance Rubber Products Sdn. Bhd.
Lot 2716&2720, Mk 7, Kawasan
Perindustrian Bukit Panchor
Nibong Tebal, Pulau Pinang,  MY 14300
Applicant Contact CHUA HOOI KOON
Correspondent
Alliance Rubber Products Sdn. Bhd.
Lot 2716&2720, Mk 7, Kawasan
Perindustrian Bukit Panchor
Nibong Tebal, Pulau Pinang,  MY 14300
Correspondent Contact CHUA HOOI KOON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/26/1999
Decision Date 10/15/1999
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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