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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 K973551
Device Name MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
Applicant
Pwa Industries Sdn. Bhd.
Batu 15-1/2, Sungai Pelong
Sungai Buloh, Selangor, D.E.,  MY 47000
Applicant Contact AZMAN ISMAIL
Correspondent
Pwa Industries Sdn. Bhd.
Batu 15-1/2, Sungai Pelong
Sungai Buloh, Selangor, D.E.,  MY 47000
Correspondent Contact AZMAN ISMAIL
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/19/1997
Decision Date 11/06/1997
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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