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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 K994206
Device Name SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLOR
Applicant
Shijiazhuang Hongray Plastic Products Co., Ltd.
# 135 Xin-Hua W. Rd.
Shijiazhuang City
Hebei Province,  CN 050081
Applicant Contact GUI-XI LIU
Correspondent
Shijiazhuang Hongray Plastic Products Co., Ltd.
# 135 Xin-Hua W. Rd.
Shijiazhuang City
Hebei Province,  CN 050081
Correspondent Contact GUI-XI LIU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received12/14/1999
Decision Date 02/07/2000
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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