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FDA 510(k) Application Details - K202003
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K202003
Device Name
Polymer Patient Examination Glove
Applicant
GMP Medicare SDN BHD
Lot/PT 64593, Jalan Dahlia/KU8, Kawasan
Perindustrian Meru Timur,
Klang 41050 MY
Other 510(k) Applications for this Company
Contact
Noraini Binti
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
07/20/2020
Decision Date
02/24/2021
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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