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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 a medical device manufactured by Barco Tekstil Sanayi VE Ticaret A.S.. It received FDA 510(k) clearance on 2022-07-22 under approval 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. It is manufactured by Barco Tekstil Sanayi VE Ticaret A.S.. The 510(k) number is K211399.

When was Sterile Level 3 Surgical Gown approved by the FDA?

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

What company makes Sterile Level 3 Surgical Gown?

Sterile Level 3 Surgical Gown is manufactured by Barco Tekstil Sanayi VE Ticaret A.S..

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 Clinical Trials

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026)

Related Devices (Code: FYA)

K162442ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500Gri Medical & Electrical Technology Co., Ltd. K150598Blockade Surgical GownMedline Industries, Inc. K153255Aero Chrome* Breathable Performance Surgical GownHalyard Health, Inc. K172445RoyalGuard Surgical Gown, i600, BreathableGri Medical & Electrical Technology Co., Ltd. K170762Cardinal Health Non-Reinforced Surgical GownCardinal Health200, LLC K162930Aero Chrome* Select Breathable Performance Surgical GownsHalyard Health, Inc.

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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