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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 K895617
Device Name PATIENT EXAMINATION GLOVES
Applicant
Lit Seng Development Sdn. Bhd.
29a, Jalan Ss 24/8, Taman
Megah, 47301 Petaling Jaya
S.D.E., West Malaysia,  MY
Applicant Contact KI HUA
Correspondent
Lit Seng Development Sdn. Bhd.
29a, Jalan Ss 24/8, Taman
Megah, 47301 Petaling Jaya
S.D.E., West Malaysia,  MY
Correspondent Contact KI HUA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/19/1989
Decision Date 01/22/1990
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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