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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 K994099
Device Name VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED
Applicant
Evergreen Medical Produts (Jingxing) Co., Ltd.
The N. Of Beishimen Village
#1,Evergreen Rd., Xiazuo Town
Shijiazhuang City,Hebei Prov.,  CN 050306
Applicant Contact DOREEN FENG
Correspondent
Evergreen Medical Produts (Jingxing) Co., Ltd.
The N. Of Beishimen Village
#1,Evergreen Rd., Xiazuo Town
Shijiazhuang City,Hebei Prov.,  CN 050306
Correspondent Contact DOREEN FENG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received12/03/1999
Decision Date 04/12/2000
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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