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FDA 510(k) Application Details - K212848
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K212848
Device Name
Surgeon'S Gloves
Applicant
Pentavest Holdings Sdn Bhd
No. 9574-9578, Jalan PTB 2 , Kawasan Perindustrian Tangga,
Batu 76400 MY
Other 510(k) Applications for this Company
Contact
Teng Boon Joo
Other 510(k) Applications for this Contact
Regulation Number
878.4460
More FDA Info for this Regulation Number
Classification Product Code
KGO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/07/2021
Decision Date
12/27/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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