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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 K931798
Device Name PATIENT EXAMINATION GLOVES
Applicant
Graintrade , Ltd.
G.P.O. Box 1767
Bangkok 10501 Thailand,  TH
Applicant Contact MOHAN
Correspondent
Graintrade , Ltd.
G.P.O. Box 1767
Bangkok 10501 Thailand,  TH
Correspondent Contact MOHAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/12/1993
Decision Date 03/28/1994
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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