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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 K052923
Device Name GREAT GLOVE POWDER FREE VINYL EXAMINATION GLOVES
Applicant
Great Glove (China), Inc.
3-4 Floor, #16 Hua Chang Rd.
Zhangjiagang, Jiangsu,  CN 215600
Applicant Contact K.M. LEE
Correspondent
Great Glove (China), Inc.
3-4 Floor, #16 Hua Chang Rd.
Zhangjiagang, Jiangsu,  CN 215600
Correspondent Contact K.M. LEE
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received10/18/2005
Decision Date 12/21/2005
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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