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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 K894796
Device Name LATEX PATIENT EXAMINATION GLOVE
Applicant
Bh Limela Industries Sdn. Bhd.
# 2475, Mk. 1, Lorong
Perusahaan 8-B,Prai Industrial
Estate, 13600 Prai, P.W.,  MY
Applicant Contact B. H LIM
Correspondent
Bh Limela Industries Sdn. Bhd.
# 2475, Mk. 1, Lorong
Perusahaan 8-B,Prai Industrial
Estate, 13600 Prai, P.W.,  MY
Correspondent Contact B. H LIM
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/28/1989
Decision Date 09/26/1989
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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