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FDA 510(k) Application Details - K231439
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K231439
Device Name
Polymer Patient Examination Glove
Applicant
S&S Glove Corporation
Lot 4, D6 Road, Dat Do I Industrial Park
Phuoc Long Tho Commune
Ba Ria-Vung Tau VN790000 VN
Other 510(k) Applications for this Company
Contact
Poppy Farrah Rossa
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LZA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/17/2023
Decision Date
08/11/2023
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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