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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 K101760
Device Name ELEGANT BLUE, WHITE, PINK POWDER FREE, NITRILE EXAMINATION GLOVES
Applicant
Profit Point Manufacturing Sdn Bhd
Jalan Mersing
Kawasan Peridustria
Kluang, Johor,  MY 86000
Applicant Contact ROBERT HILL
Correspondent
Profit Point Manufacturing Sdn Bhd
Jalan Mersing
Kawasan Peridustria
Kluang, Johor,  MY 86000
Correspondent Contact ROBERT HILL
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
JDI   LWJ   LZO  
Date Received06/23/2010
Decision Date 10/06/2010
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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