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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 K892465
Device Name NON-STERILE PATIENT EXAMINATION GLOVES
Applicant
Crocker Industrial Resources Sdn. Bhd.
Plo 38, Senai Industrial Area,
Phase 2
Senai, Johor,  MY 81400
Applicant Contact NAIDU
Correspondent
Crocker Industrial Resources Sdn. Bhd.
Plo 38, Senai Industrial Area,
Phase 2
Senai, Johor,  MY 81400
Correspondent Contact NAIDU
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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