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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 K010247
Device Name SHANGHAI CHINASTAR POWER-FREE BLUE NITRIL EXAMINATION GLOVES
Applicant
Shanghai China Star Corp
# 283, Che Xing Rd.
Che Dun Zhen,Song Jiang County
Shanghai,  CN
Applicant Contact LEE HUNG TE CHIH
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Correspondent Contact NED E DEVINE
Regulation Number880.6250
Classification Product Code
LZA  
Date Received01/26/2001
Decision Date 02/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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