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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 K981917
Device Name POWDER FREE (CHLORINATED) LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Applicant
Oon Corp. Resources
59 Senawang Industrial Estate
Seremban,  MY 70450
Applicant Contact CLEMENT K.K OON
Correspondent
Oon Corp. Resources
59 Senawang Industrial Estate
Seremban,  MY 70450
Correspondent Contact CLEMENT K.K OON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/01/1998
Decision Date 12/07/1998
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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