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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 K993127
Device Name MULTI-COMFORT NITRILE EXAMINATION GLOVES, (POWDER FREE)
Applicant
Glovesworld Industries Sdn. Bhd.
Lot Pt. 153, Kawasan
Perusahaan Beranang, Mukim
Beranang, Selangor, D.E.,  MY 43700
Applicant Contact BIEN LONG NIEN
Correspondent
Glovesworld Industries Sdn. Bhd.
Lot Pt. 153, Kawasan
Perusahaan Beranang, Mukim
Beranang, Selangor, D.E.,  MY 43700
Correspondent Contact BIEN LONG NIEN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/20/1999
Decision Date 12/02/1999
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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