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FDA 510(k) Application Details - K214110
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K214110
Device Name
Polymer Patient Examination Glove
Applicant
Mah Sing Healthcare Sdn Bhd
Wisma Mah Sing, Penthouse Suite 1, 163 Jalan Sungai Besi
Kuala Lumpur 57100 MY
Other 510(k) Applications for this Company
Contact
Sazalinda Musa
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
12/29/2021
Decision Date
02/19/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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