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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 K984020
Device Name POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS)
Applicant
Kossan Latex Industries(M)Sdn Bhd
Lot 16632, 5-1/4 Miles,
Jalan Meru
Klang, Selangor,  MY 41050
Applicant Contact BOB CHAN
Correspondent
Kossan Latex Industries(M)Sdn Bhd
Lot 16632, 5-1/4 Miles,
Jalan Meru
Klang, Selangor,  MY 41050
Correspondent Contact BOB CHAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/12/1998
Decision Date 12/23/1998
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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