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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 K024216
Device Name TOP GLOVE VINYL EXAMINATION GLOVE
Applicant
Top Glove (Zhangjiagang) Co. , Ltd.
3, Zhangjiagang Xi Tang Rd.
Xi Zhang Town,  CN 215614
Applicant Contact LIM WEE CHAI
Correspondent
Top Glove (Zhangjiagang) Co. , Ltd.
3, Zhangjiagang Xi Tang Rd.
Xi Zhang Town,  CN 215614
Correspondent Contact LIM WEE CHAI
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received12/23/2002
Decision Date 02/27/2003
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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