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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 K892985
Device Name PATIENT EXAMINATION GLOVES
Applicant
Eac Rubber Industries (M) Sdn. Bhd.
P.O. Box 240
46720 Petaling Jaya
Malaysia,  MY
Applicant Contact SHERMAN WONG
Correspondent
Eac Rubber Industries (M) Sdn. Bhd.
P.O. Box 240
46720 Petaling Jaya
Malaysia,  MY
Correspondent Contact SHERMAN WONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/12/1989
Decision Date 06/06/1989
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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