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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Glove, Specialty
510(k) Number K190159
Device Name Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove
Applicant
Showa Best Glove, Inc.
579 Edison St.
Menlo,  GA  30731
Applicant Contact Jefferey Richardson
Correspondent
Bakerhostetler
1050 Connecticut Ave., NW
Suite 1100
Washington,  DC  20036
Correspondent Contact Lee Rosebush
Regulation Number880.6250
Classification Product Code
LZC  
Date Received01/30/2019
Decision Date 05/06/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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