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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 K905033
Device Name SLIMFLEX, PATIENT EXAMINATION GLOVES
Applicant
Slim River Latex Sdn. Bhd.
2582 Mk.1, Lorong Perusahaan
8-C, Kawasan Perindustrian
Perai, 13600 Perai, Malay,  MY
Applicant Contact LYNE CHING
Correspondent
Slim River Latex Sdn. Bhd.
2582 Mk.1, Lorong Perusahaan
8-C, Kawasan Perindustrian
Perai, 13600 Perai, Malay,  MY
Correspondent Contact LYNE CHING
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/07/1990
Decision Date 11/19/1990
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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