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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K992588
Device Name BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE
Applicant
Formosa Glove Industrial Co., Ltd.
1016 Seward Ave.
Westfield,  NJ  07090
Applicant Contact TIANG S CHANG
Correspondent
Formosa Glove Industrial Co., Ltd.
1016 Seward Ave.
Westfield,  NJ  07090
Correspondent Contact TIANG S CHANG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/02/1999
Decision Date 09/10/1999
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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