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FDA 510(k) Application Details - K041379
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K041379
Device Name
Vinyl Patient Examination Glove
Applicant
SHIJIAZHUANG WALLY PLASTICS CO., LTD
NO 78 TONGDA RD.
JINZHOU CITY, HEBEI 052260 CN
Other 510(k) Applications for this Company
Contact
IRIS YANG
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
05/24/2004
Decision Date
08/31/2004
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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