Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K201829
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K201829
Device Name
Surgeon'S Gloves
Applicant
Medline Industries, Inc.
Three Lakes Drive
Northfield, IL 60030 US
Other 510(k) Applications for this Company
Contact
Jennifer Mason
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
07/02/2020
Decision Date
09/09/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact