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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 K930795
Device Name MEDIGLOVES, FISHERBRAND, MEDIPRODUCTS GLOVES
Applicant
Medigloves , Ltd.
33/3 Moo 2 Tivanont Rd.
Pathumtani,  TH 12000
Applicant Contact JORAM HIRSCH
Correspondent
Medigloves , Ltd.
33/3 Moo 2 Tivanont Rd.
Pathumtani,  TH 12000
Correspondent Contact JORAM HIRSCH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/16/1993
Decision Date 02/03/1994
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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