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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 K002448
Device Name LATEX EXAMINATION GLOVES, POWDERED, (CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM).
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 Received08/09/2000
Decision Date 09/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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