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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K993231
Device Name SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES
Applicant
Shinemound Enterprise, Inc.
17a Sterling Rd.
North Billerica,  MA  01862
Applicant Contact HUAN-CHUNG LI
Correspondent
Shinemound Enterprise, Inc.
17a Sterling Rd.
North Billerica,  MA  01862
Correspondent Contact HUAN-CHUNG LI
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/27/1999
Decision Date 10/27/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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