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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 K994201
Device Name RUBBERCARE POWDER-FREE, GUARDIAN POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
Applicant
Perusahaan Pelindung Getah (M) Sdn Bhd
Lot 110, Lorong Senawang 4/3
Senawang Industrial Estate
Seremban, N.S.,  MY 70450
Applicant Contact PETER YEW NIENG CHOON
Correspondent
Perusahaan Pelindung Getah (M) Sdn Bhd
Lot 110, Lorong Senawang 4/3
Senawang Industrial Estate
Seremban, N.S.,  MY 70450
Correspondent Contact PETER YEW NIENG CHOON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/13/1999
Decision Date 02/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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