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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 K902796
Device Name LATEX EXAMINATION GLOVES
Applicant
Ek Hong Rubber Industry (Thailand) Co., Ltd.
# 88/76 Moo 7 Soi Sirichai
Ekachai Rd., Tumbol Bangbon
Bangkok,  TH 10150
Applicant Contact AJIN DACHACHONGJUMRO
Correspondent
Ek Hong Rubber Industry (Thailand) Co., Ltd.
# 88/76 Moo 7 Soi Sirichai
Ekachai Rd., Tumbol Bangbon
Bangkok,  TH 10150
Correspondent Contact AJIN DACHACHONGJUMRO
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/26/1990
Decision Date 12/04/1990
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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