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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 K891123
Device Name RUBBERCARE PATIENT EXAMINATION GLOVE
Applicant
Perusahaan Pelindung Getah (M) Sdn Bhd
Lot 110, Lorong Senawang 4/3
Senawang Industrial Estate
Seremban, N.S.,  MY 70450
Applicant Contact 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 NIENG CHOON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/02/1989
Decision Date 07/14/1989
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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