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FDA 510(k)

Bodygard SFS Surgical Gown Level 4

K-Number: K221139 · 2022-11-10

ApplicantFeliks Plastik Laminasyon VE Ambalaj Malzemeleri
Decision Date2022-11-10
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Bodygard SFS Surgical Gown Level 4 is the device name listed in this FDA 510(k) record. The listed applicant is Feliks Plastik Laminasyon VE Ambalaj Malzemeleri. It received FDA 510(k) clearance on 2022-11-10 under 510(k) number K221139. 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 Bodygard SFS Surgical Gown Level 4?

Bodygard SFS Surgical Gown Level 4 is a medical device that received FDA 510(k) clearance on 2022-11-10. The listed applicant is Feliks Plastik Laminasyon VE Ambalaj Malzemeleri. The 510(k) number is K221139.

When did Bodygard SFS Surgical Gown Level 4 receive FDA 510(k) clearance?

Bodygard SFS Surgical Gown Level 4 received FDA 510(k) clearance on 2022-11-10, under 510(k) number K221139.

Who is the listed applicant for Bodygard SFS Surgical Gown Level 4?

The FDA 510(k) record lists Feliks Plastik Laminasyon VE Ambalaj Malzemeleri as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bodygard SFS Surgical Gown Level 4?

The FDA product code for Bodygard SFS Surgical Gown Level 4 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

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

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