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FDA 510(k)

Aero Blue Performance Surgical Gowns

K-Number: K192362 · 2019-12-13

ApplicantO&M Halyard, Inc.
Decision Date2019-12-13
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Aero Blue Performance Surgical Gowns is the device name listed in this FDA 510(k) record. The listed applicant is O&M Halyard, Inc.. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K192362. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aero Blue Performance Surgical Gowns?

Aero Blue Performance Surgical Gowns is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is O&M Halyard, Inc.. The 510(k) number is K192362.

When did Aero Blue Performance Surgical Gowns receive FDA 510(k) clearance?

Aero Blue Performance Surgical Gowns received FDA 510(k) clearance on 2019-12-13, under 510(k) number K192362.

Who is the listed applicant for Aero Blue Performance Surgical Gowns?

The FDA 510(k) record lists O&M Halyard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aero Blue Performance Surgical Gowns?

The FDA product code for Aero Blue Performance Surgical Gowns is FYA.

Other records listing O&M Halyard, Inc. as applicant

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Related Devices (Code: FYA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261028Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd.K261949NYES Tuff Cuff L3 Disposable GownsNew York Embroidery StudioK252575Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)New York Embroidery Studio (NYES)K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V.K253243Cardinal Health™ Poly Reinforced Surgical GownCardinal Health 200, LLCK253003Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)Hubei Xinxin Non-Woven Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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