510(k) clearances

Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)

Owens & Minor (O&M) Halyard, Inc. · General, Plastic Surgery

K232849Substantially EquivalentAbbreviatedFYC
Open FDA's page for this record
Third party flag
N
City
Mechanicsville
Advisory committee description
General, Plastic Surgery
Address 1
9120 Lockwood Blvd.
Statement or summary
Summary
Product code
FYC
Zip code
23116
Applicant
Owens & Minor (O&M) Halyard, Inc.
Decision date
2024-05-16
Decision code
SESE
Country code
US
Device name
Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)
Advisory committee
SU
Contact
Gabriel Dockery
K number
K232849
State
VA
Date received
2023-09-14
Review advisory committee
HO
Postal code
23116
Decision description
Substantially Equivalent
Clearance type
Abbreviated
Harmonized identifiers (openFDA)
Device name
Gown, Isolation, Surgical
Medical specialty description
General, Plastic Surgery
Regulation number
878.4040
Device class
2
Registration number
3016678045, 3017467279, 3011545608, 1423205, 3007838093, 3003495693, 1417592, 1054241, 9616096, 1018470, 3017180923, 3013260641, 3005599545, 3014421917, 3003561450, 1043214, 3016844398, 3004158259, 3010155681, 3016763307, 3014925393, 3011547453, 3006723155, 1055236, 3016680688, 3015140351, 9615270, 3026536498, 9680646, 3017494520, 3006400329, 3017171460, 3013502418, 3004111573, 9680222, 2648727, 9611959, 1423537, 3017896419, 3016705853 +18 more
FEI number
3003807323, 3016678045, 3017467279, 3011545608, 3003495693, 3007838093, 1417592, 3002677549, 1018470, 3017180923, 3013260641, 3005599545, 3014421917, 3003561450, 1043214, 3016844398, 3004158259, 3010155681, 3016763307, 3014925393, 3003154916, 3011547453, 3006723155, 1000112877, 3003040625, 3016680688, 3015140351, 3026536498, 3002750002, 3017494520, 3006400329, 3003753496, 3013502418, 3017171460, 3004111573, 3003792528, 1000582923, 2648727, 3001236905, 3016705853 +18 more
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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.