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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 K953138
Device Name MEDI-PLUS, HEALTH PLUS, SANITEX, RELIANCE
Applicant
Pwa Industries Sdn. Bhd.
Batu 15 1/2 Sungai Pelong
47000, Sungai Buloh
Selangor Darul Ehsan,  MY 47000
Applicant Contact AZMAN ISMAIL
Correspondent
Pwa Industries Sdn. Bhd.
Batu 15 1/2 Sungai Pelong
47000, Sungai Buloh
Selangor Darul Ehsan,  MY 47000
Correspondent Contact AZMAN ISMAIL
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/06/1995
Decision Date 09/22/1995
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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