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FDA 510(k)

Medline Level 4 Surgical Gown with Breathable Sleeves

K-Number: K242844 · 2025-02-26

ApplicantMedline Industries, LP
Decision Date2025-02-26
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medline Level 4 Surgical Gown with Breathable Sleeves is a medical device manufactured by Medline Industries, LP. It received FDA 510(k) clearance on 2025-02-26 under approval number K242844. 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 Medline Level 4 Surgical Gown with Breathable Sleeves?

Medline Level 4 Surgical Gown with Breathable Sleeves is a medical device that received FDA 510(k) clearance on 2025-02-26. It is manufactured by Medline Industries, LP. The 510(k) number is K242844.

When was Medline Level 4 Surgical Gown with Breathable Sleeves approved by the FDA?

Medline Level 4 Surgical Gown with Breathable Sleeves received FDA 510(k) clearance on 2025-02-26, under approval number K242844.

What company makes Medline Level 4 Surgical Gown with Breathable Sleeves?

Medline Level 4 Surgical Gown with Breathable Sleeves is manufactured by Medline Industries, LP.

What is the FDA product code for Medline Level 4 Surgical Gown with Breathable Sleeves?

The FDA product code for Medline Level 4 Surgical Gown with Breathable Sleeves is FYA.

Related Clinical Trials

NCT07609888 Photodynamic Therapy as an Adjunct to Non-Surgical Periodontal Therapy in Stage II Periodontitis: A Randomized Split-Mouth Study COMPLETED NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT07422623 Hallux Valgus Correction Surgery Recovery Using Semiconductor Embedded Therapeutic Sleeves ENROLLING_BY_INVITATION NCT02747485 Impact of Diffuse Myocardial Fibrosis on the Ventricular Function in Regurgitant Left-Sided Valve Heart Diseases ( The DIFFUsE Study) ACTIVE_NOT_RECRUITING NCT04859725 HyperSpectral Imaging in Low Grade Glioma ACTIVE_NOT_RECRUITING NCT07580664 Long-term Assessment of BDyn Dynamic Stabilization Device in Patients With Lumbar Degenerative Disc Disease NOT_YET_RECRUITING

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)

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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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