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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 K892352
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Norsechem Latex Products (M) Sdn Bhd
# 3, Jalan Panglima
30000 Ipoh, Perak
Malaysia,  MY
Applicant Contact HEE CHEW
Correspondent
Norsechem Latex Products (M) Sdn Bhd
# 3, Jalan Panglima
30000 Ipoh, Perak
Malaysia,  MY
Correspondent Contact HEE CHEW
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/23/1989
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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