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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 K992175
Device Name EXTRA-CARE LATEX PATIENT EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
Applicant
Ultrawin Sdn Bhd
Lot 2, Pesiaran Perindustrian
Kanthan 2
Chemor, Perak,  MY 31200
Applicant Contact MELANIE LIM
Correspondent
Ultrawin Sdn Bhd
Lot 2, Pesiaran Perindustrian
Kanthan 2
Chemor, Perak,  MY 31200
Correspondent Contact MELANIE LIM
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/28/1999
Decision Date 09/24/1999
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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