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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 K891271
Device Name PATIENT EXAMINATION GLOVE (LATEX)
Applicant
Dr. Boo Co., Ltd.
C/O Omni Trade Group, Inc.
3131 Turtle Creek Blvd.,Ste 500
Dallas,  TX  75219
Applicant Contact MARK S CONNOLLY
Correspondent
Dr. Boo Co., Ltd.
C/O Omni Trade Group, Inc.
3131 Turtle Creek Blvd.,Ste 500
Dallas,  TX  75219
Correspondent Contact MARK S CONNOLLY
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/09/1989
Decision Date 03/22/1989
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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