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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 K980754
Device Name CIR LATEX EXAMINATION GLOVES, NON-STERILE, POWDERED, WITH PROTEIN LABELING CLAIM OF <=200 UG/G
Applicant
Crocker Industrial Resources Sdn. Bhd.
Plo 38, Senai Industrial Area,
Phase 2
Senai, Johor,  MY 81400
Applicant Contact CHONG LEE CHUAN
Correspondent
Crocker Industrial Resources Sdn. Bhd.
Plo 38, Senai Industrial Area,
Phase 2
Senai, Johor,  MY 81400
Correspondent Contact CHONG LEE CHUAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/26/1998
Decision Date 05/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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