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FDA 510(k) Application Details - K213681
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K213681
Device Name
Polymer Patient Examination Glove
Applicant
Ivory Gloves SDN. BHD.
Lot 7806 Jalan Perusahaan 1, Kawasan Perindustrian
Kamunting 34600 MY
Other 510(k) Applications for this Company
Contact
Arasi No Last Name Provided
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
11/22/2021
Decision Date
04/21/2022
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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