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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 K931427
Device Name LATEX EXAMINATION GLOVE POWDER FREE FORMTEX
Applicant
FORMTEX MEDICAL SDN. BHD.
7, leboh hishamuddin satu kaw.
20 kawasan perusahaan selat
klang pelabohan klang,  MY 42000
Applicant Contact peng hock
Correspondent
FORMTEX MEDICAL SDN. BHD.
7, leboh hishamuddin satu kaw.
20 kawasan perusahaan selat
klang pelabohan klang,  MY 42000
Correspondent Contact peng hock
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/25/1993
Decision Date 10/15/1993
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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