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FDA 510(k) Application Details - K190080
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K190080
Device Name
Polymer Patient Examination Glove
Applicant
Comfort Rubber Gloves Industries Sdn. Bhd.
Lot 821, Jalan Matang
Matang 34750 MY
Other 510(k) Applications for this Company
Contact
Chan Yew Men
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
01/16/2019
Decision Date
06/27/2019
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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