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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 K892749
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Industri Leva Sdn. Bhd.
207-G Dato Keramat Rd.
Penang,  MY 10150
Applicant Contact CHIANG KIANG
Correspondent
Industri Leva Sdn. Bhd.
207-G Dato Keramat Rd.
Penang,  MY 10150
Correspondent Contact CHIANG KIANG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/11/1989
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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