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FDA 510(k)

Disposable Surgical Face Mask (M01, M02)

K-Number: K220512 · 2022-04-25

ApplicantFomed Industries, Inc.
Decision Date2022-04-25
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Surgical Face Mask (M01, M02) is the device name listed in this FDA 510(k) record. The listed applicant is Fomed Industries, Inc.. It received FDA 510(k) clearance on 2022-04-25 under 510(k) number K220512. 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 Disposable Surgical Face Mask (M01, M02)?

Disposable Surgical Face Mask (M01, M02) is a medical device that received FDA 510(k) clearance on 2022-04-25. The listed applicant is Fomed Industries, Inc.. The 510(k) number is K220512.

When did Disposable Surgical Face Mask (M01, M02) receive FDA 510(k) clearance?

Disposable Surgical Face Mask (M01, M02) received FDA 510(k) clearance on 2022-04-25, under 510(k) number K220512.

Who is the listed applicant for Disposable Surgical Face Mask (M01, M02)?

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

What is the FDA product code for Disposable Surgical Face Mask (M01, M02)?

The FDA product code for Disposable Surgical Face Mask (M01, M02) is FXX.

Other records listing Fomed Industries, Inc. as applicant

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.

K250735Dental Barrier and Sleeves

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

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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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