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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 K971415
Device Name VINYL PATIENT EXAMINATION GLOVE, POWDER-FREE
Applicant
Shanghai Foremost Plastic Industrial Co., Ltd.
Yan Lin Rover Bridge E.
Che Xing Hwy. Che Dun Town
Songjiang County, Shanghai,  CN 201611
Applicant Contact TIANG S CHANG
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462
Correspondent Contact ROBERT MOSENKIS
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/17/1997
Decision Date 05/23/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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