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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 K896220
Device Name NON-STERILE LATEX EXAMINATION GLOVES
Applicant
Allstar Sdn. Bhd.
Lot 16, Lengkongan Hishamuddin
Kawasan Perusahaan, S.K.U.
42000 Kelang, Selangor,  MY
Applicant Contact SEANG HOE
Correspondent
Allstar Sdn. Bhd.
Lot 16, Lengkongan Hishamuddin
Kawasan Perusahaan, S.K.U.
42000 Kelang, Selangor,  MY
Correspondent Contact SEANG HOE
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/30/1989
Decision Date 12/05/1989
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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