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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 K003934
Device Name POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
Applicant
Seltom Pacific Sdn. Bhd.
Beranang
Mukim Beranang
Selangor Darul Ehsan,  MY 43700
Applicant Contact S. SEAGARAN
Correspondent
Seltom Pacific Sdn. Bhd.
Beranang
Mukim Beranang
Selangor Darul Ehsan,  MY 43700
Correspondent Contact S. SEAGARAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/20/2000
Decision Date 01/26/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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