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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 K991849
Device Name NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER EXTRAC
Applicant
Seal Polymer Industries Bhd.
Lt 72706, Jalan Lahat, Kawasan
Perindustrian Bukit Merah
Lahat, Ipoh, Perak,  MY 31500
Applicant Contact CHAN CHIN HONG
Correspondent
Seal Polymer Industries Bhd.
Lt 72706, Jalan Lahat, Kawasan
Perindustrian Bukit Merah
Lahat, Ipoh, Perak,  MY 31500
Correspondent Contact CHAN CHIN HONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/01/1999
Decision Date 07/07/1999
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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