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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 K924357
Device Name LATEX PATIENT EXAMINATION GLOVES
Applicant
Asia Pacific Latex Sdn Bhd
# 14, Jalan Taiping,
33000 Kuala Kangsar, Perak
Darul Ridzuan, Malaysia,  ML
Applicant Contact HONG LEE
Correspondent
Asia Pacific Latex Sdn Bhd
# 14, Jalan Taiping,
33000 Kuala Kangsar, Perak
Darul Ridzuan, Malaysia,  ML
Correspondent Contact HONG LEE
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/25/1992
Decision Date 02/03/1994
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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