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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 K933224
Device Name SLIMFLEX - POWDER FREE LATEX EXAMINATION GLOVES
Applicant
Slim River Latex Sdn. Bhd.
2582 Mk.1, Lorong Perusahaan
8-C, Kawasan Perindustrian
Perai, 13600 Perai, Malay,  MY
Applicant Contact LEONG LYNE CHING
Correspondent
Slim River Latex Sdn. Bhd.
2582 Mk.1, Lorong Perusahaan
8-C, Kawasan Perindustrian
Perai, 13600 Perai, Malay,  MY
Correspondent Contact LEONG LYNE CHING
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/01/1993
Decision Date 03/15/1994
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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