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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 K001485
Device Name HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE LATEX EXAMINATION GLOVES
Applicant
Pwa Industries Sdn. Bhd.
Lot 93, Semambu Indust. Estate
Kuantan, Pahang,  MY 25350
Applicant Contact AZHARSYAH M YASSIN
Correspondent
Pwa Industries Sdn. Bhd.
Lot 93, Semambu Indust. Estate
Kuantan, Pahang,  MY 25350
Correspondent Contact AZHARSYAH M YASSIN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/12/2000
Decision Date 06/13/2000
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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