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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 K941240
Device Name DR. BOO POWDER-FREE LATEX EXAM GLOVES
Applicant
Dr. Boo Co., Ltd.
Suite #1102-11th Floor Wall St.
Tower Bldg. 33/48 Suriwong Rd.
Bangkok Thailand,  TH 10500
Applicant Contact SOMBOON VARABUNTOONVIT
Correspondent
Dr. Boo Co., Ltd.
Suite #1102-11th Floor Wall St.
Tower Bldg. 33/48 Suriwong Rd.
Bangkok Thailand,  TH 10500
Correspondent Contact SOMBOON VARABUNTOONVIT
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/15/1994
Decision Date 06/21/1994
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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