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FDA 510(k)

Medline Surgical Face Mask and Medline Procedural Face Mask

K-Number: K223236 · 2023-03-24

ApplicantMedline Industries, LP
Decision Date2023-03-24
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medline Surgical Face Mask and Medline Procedural Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, LP. It received FDA 510(k) clearance on 2023-03-24 under 510(k) number K223236. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline Surgical Face Mask and Medline Procedural Face Mask?

Medline Surgical Face Mask and Medline Procedural Face Mask is a medical device that received FDA 510(k) clearance on 2023-03-24. The listed applicant is Medline Industries, LP. The 510(k) number is K223236.

When did Medline Surgical Face Mask and Medline Procedural Face Mask receive FDA 510(k) clearance?

Medline Surgical Face Mask and Medline Procedural Face Mask received FDA 510(k) clearance on 2023-03-24, under 510(k) number K223236.

Who is the listed applicant for Medline Surgical Face Mask and Medline Procedural Face Mask?

The FDA 510(k) record lists Medline Industries, LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline Surgical Face Mask and Medline Procedural Face Mask?

The FDA product code for Medline Surgical Face Mask and Medline Procedural Face Mask is FXX.

Related Clinical Trials

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.

NCT07432607High-Flow Nasal Oxygen vs. Face Mask During Sedoanalgesia in Non-Intubated Thoracoscopic Pericardial Window SurgeryRECRUITINGNCT07718295HFNO Versus Face Mask for Cerebral Oxygenation During Procedural SedationRECRUITING

Other records listing Medline Industries, LP as applicant

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Related Devices (Code: FXX)

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.

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading 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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