510(k) clearances

Medline Level 4 Surgical Gown with Breathable Sleeves

Medline Industries, LP · General, Plastic Surgery

K242844Substantially EquivalentTraditionalFYA
Open FDA's page for this record
Third party flag
N
City
Northfiled
Advisory committee description
General, Plastic Surgery
Address 1
Three Lakes Dr.
Statement or summary
Summary
Product code
FYA
Zip code
60093
Applicant
Medline Industries, LP
Decision date
2025-02-26
Decision code
SESE
Country code
US
Device name
Medline Level 4 Surgical Gown with Breathable Sleeves
Advisory committee
SU
Contact
Kelsey Closen
K number
K242844
State
IL
Date received
2024-09-20
Review advisory committee
HO
Postal code
60093
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Gown, Surgical
Medical specialty description
General, Plastic Surgery
Regulation number
878.4040
Device class
2
Registration number
3030088999, 3006437555, 3030446844, 3000268902, 9616088, 3006538822, 3013298431, 1527185, 3004122598, 3008502431, 3014479313, 3005997949, 3015058854, 8030672, 3006113262, 3008837339, 3018781093, 3014421917, 3003561450, 3002806603, 2029015, 3016763307, 3014925393, 3034226814, 3005748481, 3030067857, 3008328679, 3025771437, 3004361903, 1061124, 1055236, 3004362278, 3006425876, 3016680688, 3026383899, 3020163307, 3019798849, 3008352384, 3016761372, 3026536498 +188 more
FEI number
3030088999, 3006437555, 3008373372, 3000268902, 3030446844, 3006538822, 3013298431, 1527185, 3004122598, 3008502431, 3014479313, 1000160458, 3005997949, 3002805559, 3015058854, 3006113262, 3008837339, 3018781093, 3014421917, 3003561450, 3002806603, 3016763307, 3014925393, 3034226814, 3005748481, 3030067857, 2523865, 3008328679, 3025771437, 3004361903, 3003094575, 3004362278, 3006425876, 3016680688, 3026383899, 3020163307, 3019798849, 3008352384, 3016761372, 3026536498 +188 more
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.