FDA 510(k)

Surgical Face Mask

K-Number: K200847 · 2020-04-23

Decision Date2020-04-23

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Surgical Face Mask is a medical device manufactured by Mexpo International, Inc.. It received FDA 510(k) clearance on 2020-04-23 under approval number K200847. 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 Surgical Face Mask?

Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2020-04-23. It is manufactured by Mexpo International, Inc.. The 510(k) number is K200847.

When was Surgical Face Mask approved by the FDA?

Surgical Face Mask received FDA 510(k) clearance on 2020-04-23, under approval number K200847.

What company makes Surgical Face Mask?

Surgical Face Mask is manufactured by Mexpo International, Inc..

What is the FDA product code for Surgical Face Mask?

The FDA product code for Surgical Face Mask is FXX.

Other Devices by Mexpo International, Inc.

K210388Non Sterile Nitrile Powder Free Examination Gloves Blue, Green and Black color

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.