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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 K051318
Device Name POWDER FREE NITRILE EXAMINATION GLOVES (WHITE, BLUE, AND PURPLE COLOR)
Applicant
Platinum Glove Industries Sdn. Bhd.
4015a, Floor 4,President Hse,
Jln Sultan Ismail
Kuala Lumpur,  MY 50250
Applicant Contact SO SOON CHEAW
Correspondent
Platinum Glove Industries Sdn. Bhd.
4015a, Floor 4,President Hse,
Jln Sultan Ismail
Kuala Lumpur,  MY 50250
Correspondent Contact SO SOON CHEAW
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/20/2005
Decision Date 06/17/2005
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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