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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 K892779
Device Name PATIENT EXAMINATION GLOVES
Applicant
Jamuri Sdn. Bhd.
20a, Jln. Kuning Tmn. Bkt.
Pasir
Batu Pahat Johore,  MY 83000
Applicant Contact TEM HUAT
Correspondent
Jamuri Sdn. Bhd.
20a, Jln. Kuning Tmn. Bkt.
Pasir
Batu Pahat Johore,  MY 83000
Correspondent Contact TEM HUAT
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/11/1989
Decision Date 01/02/1990
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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