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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 K034060
Device Name DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR (SENSI-PRO)
Applicant
Hong Huang Tang Industrial Co., Ltd.
17a Sterling Rd.
North Billerica,  MA  01862
Applicant Contact HUAN-CHUNG LI
Correspondent
Hong Huang Tang Industrial Co., Ltd.
17a Sterling Rd.
North Billerica,  MA  01862
Correspondent Contact HUAN-CHUNG LI
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received12/31/2003
Decision Date 02/06/2004
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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