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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 K943434
Device Name PATIENT EXAMINATION GLOVES
Applicant
Pacewell Sdn Bhd
Lot 72706,Jalen Lahat,Kawasan
Perindustrian Bukit Merah
Lahat,Perak,  MY 31500
Applicant Contact NG CHAI CHAH
Correspondent
Pacewell Sdn Bhd
Lot 72706,Jalen Lahat,Kawasan
Perindustrian Bukit Merah
Lahat,Perak,  MY 31500
Correspondent Contact NG CHAI CHAH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/18/1994
Decision Date 09/26/1994
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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