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FDA 510(k) Application Details - K992860
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K992860
Device Name
Vinyl Patient Examination Glove
Applicant
SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD.
NO. 135 XIN-HUA WEST ROAD
HIJIAZHUANG CITY
HEBEI PROVINCE 050081 CN
Other 510(k) Applications for this Company
Contact
GUI-XI LIU
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/25/1999
Decision Date
09/24/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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