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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 K002114
Device Name RUBBERCARE GUARDIAN POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVES: CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER
Applicant
PERUSAHAAN PELINDUNG GETAH (M) SDN BHD
EMPAT, SENAWANG INDUSTRIAL
ESTATE, 70450 SEREMBAN, NEGERI
SEMBILAN DARUL KHUSUS MALAYSIA,  ML
Applicant Contact PETER YEW NIENG CHOON
Correspondent
PERUSAHAAN PELINDUNG GETAH (M) SDN BHD
EMPAT, SENAWANG INDUSTRIAL
ESTATE, 70450 SEREMBAN, NEGERI
SEMBILAN DARUL KHUSUS MALAYSIA,  ML
Correspondent Contact PETER YEW NIENG CHOON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/12/2000
Decision Date 08/11/2000
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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