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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 K120110
Device Name ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET
Applicant
Profit Point Manufacturing Sdn Bhd
Lot Ptd 27735 (Plo 9)
26624 (Plo 18)
Kluang,  MY 86000
Applicant Contact ROBERT HILL
Correspondent
Profit Point Manufacturing Sdn Bhd
Lot Ptd 27735 (Plo 9)
26624 (Plo 18)
Kluang,  MY 86000
Correspondent Contact ROBERT HILL
Regulation Number880.6250
Classification Product Code
LZA  
Date Received01/13/2012
Decision Date 10/04/2012
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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