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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 K993454
Device Name POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL CLAIM - 50 MICROGRAMS OR LESS)
Applicant
Sri Johani Sdn. Bhd.
Lot Pt 7178, Balakong N/V,
Seri Kembangan
Selangor,  MY 43300
Applicant Contact LIM LEE AIK
Correspondent
Sri Johani Sdn. Bhd.
Lot Pt 7178, Balakong N/V,
Seri Kembangan
Selangor,  MY 43300
Correspondent Contact LIM LEE AIK
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/13/1999
Decision Date 12/03/1999
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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