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FDA 510(k) Application Details - K211477
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K211477
Device Name
Latex Patient Examination Glove
Applicant
Aspen Glove Sdn. Bhd.
Aspen House, 300, JLN Macalister
Georgetown 10450 MY
Other 510(k) Applications for this Company
Contact
Iskandar Basha bin Abdul Kadir
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/12/2021
Decision Date
09/20/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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