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FDA 510(k) Application Details - K220088
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K220088
Device Name
Polymer Patient Examination Glove
Applicant
Professional Latex Sdn Bhd
Lot 20734 & 20735, Lengkungan Perusahaan Kamunting 3/1
Kawasan Perusahaan Kamunting Raya 34600 MY
Other 510(k) Applications for this Company
Contact
Kok Yoon Lim
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
01/11/2022
Decision Date
03/30/2023
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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