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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 K891805
Device Name HYGEIA EXAMINATION GLOVES
Applicant
Hygeia , Ltd.
5th Floor Panavongs Bldg.
104 Surawongse Rd.
Bangkok, Thailand,  TH
Applicant Contact CHIN CHINPILAS
Correspondent
Hygeia , Ltd.
5th Floor Panavongs Bldg.
104 Surawongse Rd.
Bangkok, Thailand,  TH
Correspondent Contact CHIN CHINPILAS
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/23/1989
Decision Date 05/12/1989
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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