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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 K991779
Device Name NITRILE EXAMINATION GLOVES POWDER FREE (BLUE)
Applicant
Seltom Pacific Sdn. Bhd.
Lot 25, Jalan Pjs 7/17
Sunway Industrial Park
Petaling Jaya, Selangor,  MY 46150
Applicant Contact S. SEGARAN
Correspondent
Seltom Pacific Sdn. Bhd.
Lot 25, Jalan Pjs 7/17
Sunway Industrial Park
Petaling Jaya, Selangor,  MY 46150
Correspondent Contact S. SEGARAN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/25/1999
Decision Date 08/11/1999
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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