FDA 510(k)

Disposable Surgical Face Mask (M01, M02)

K-Number: K220512 · 2022-04-25

Decision Date2022-04-25

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Disposable Surgical Face Mask (M01, M02) is a medical device manufactured by Fomed Industries, Inc.. It received FDA 510(k) clearance on 2022-04-25 under approval 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. It is manufactured by Fomed Industries, Inc.. The 510(k) number is K220512.

When was Disposable Surgical Face Mask (M01, M02) approved by the FDA?

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

What company makes Disposable Surgical Face Mask (M01, M02)?

Disposable Surgical Face Mask (M01, M02) is manufactured by Fomed Industries, Inc..

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 Devices by Fomed Industries, Inc.

K250735Dental Barrier and Sleeves

Related Devices (Code: FXX)

K153409Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC K160269Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd. K152197Skypro, SP01 MaskSkypro Medical Supplies Company K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. K152561Communicator Surgical Facemask with Clear WindowPrestige Ameritech , Ltd. K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap ShieldPrestige Ameritech

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.