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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 K990427
Device Name ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE
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
LZA  
Date Received02/11/1999
Decision Date 04/23/1999
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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