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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 K923089
Device Name EXAMINATION GLOVES POWDER FREE
Applicant
Glovoco (M) Sdn Bhd
Lot 2, Jalan Persiaran
Hishamuddin, Kawasan 20 Selat
Klang Satu Malaysia,  MY
Applicant Contact PENG HOCK
Correspondent
Glovoco (M) Sdn Bhd
Lot 2, Jalan Persiaran
Hishamuddin, Kawasan 20 Selat
Klang Satu Malaysia,  MY
Correspondent Contact PENG HOCK
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/25/1992
Decision Date 06/22/1993
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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