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FDA 510(k)

American-Made Surgical Mask

K-Number: K210101 · 2022-01-26

ApplicantArmbrust, Inc.
Decision Date2022-01-26
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

American-Made Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Armbrust, Inc.. It received FDA 510(k) clearance on 2022-01-26 under 510(k) number K210101. 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 American-Made Surgical Mask?

American-Made Surgical Mask is a medical device that received FDA 510(k) clearance on 2022-01-26. The listed applicant is Armbrust, Inc.. The 510(k) number is K210101.

When did American-Made Surgical Mask receive FDA 510(k) clearance?

American-Made Surgical Mask received FDA 510(k) clearance on 2022-01-26, under 510(k) number K210101.

Who is the listed applicant for American-Made Surgical Mask?

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

What is the FDA product code for American-Made Surgical Mask?

The FDA product code for American-Made Surgical Mask is FXX.

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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