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FDA 510(k) Application Details - K223221
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K223221
Device Name
Polymer Patient Examination Glove
Applicant
Dynacare Sdn Bhd
Lot 15528 (PT 5001), Kawasan Perusahaan Kampung Acheh
Sitiawan 32000 MY
Other 510(k) Applications for this Company
Contact
Chow Choong Keong
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
10/17/2022
Decision Date
01/13/2023
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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