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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 K892487
Device Name PATIENT EXAMINATION GLOVES
Applicant
Allied Rubber Industries Sdn. Bhd.
2009, Kawasan Miel
Lot 2, Jalan Beremban 15/12,
400000 Shah Alam.Malaysia,  MY
Applicant Contact EE PING
Correspondent
Allied Rubber Industries Sdn. Bhd.
2009, Kawasan Miel
Lot 2, Jalan Beremban 15/12,
400000 Shah Alam.Malaysia,  MY
Correspondent Contact EE PING
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/07/1989
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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