Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Sterile Level 3 Surgical Gown

K-Number: K211399 · 2022-07-22

ApplicantBarco Tekstil Sanayi VE Ticaret A.S.
Decision Date2022-07-22
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sterile Level 3 Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is Barco Tekstil Sanayi VE Ticaret A.S.. It received FDA 510(k) clearance on 2022-07-22 under 510(k) number K211399. 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 Sterile Level 3 Surgical Gown?

Sterile Level 3 Surgical Gown is a medical device that received FDA 510(k) clearance on 2022-07-22. The listed applicant is Barco Tekstil Sanayi VE Ticaret A.S.. The 510(k) number is K211399.

When did Sterile Level 3 Surgical Gown receive FDA 510(k) clearance?

Sterile Level 3 Surgical Gown received FDA 510(k) clearance on 2022-07-22, under 510(k) number K211399.

Who is the listed applicant for Sterile Level 3 Surgical Gown?

The FDA 510(k) record lists Barco Tekstil Sanayi VE Ticaret A.S. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Level 3 Surgical Gown?

The FDA product code for Sterile Level 3 Surgical Gown is FYA.

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.

↑