FDA 510(k)

Surgical Face Mask

K-Number: K213617 · 2022-02-11

Decision Date2022-02-11

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Surgical Face Mask is a medical device manufactured by Megasoft (China) Co., Ltd.. It received FDA 510(k) clearance on 2022-02-11 under approval number K213617. 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 2022-02-11. It is manufactured by Megasoft (China) Co., Ltd.. The 510(k) number is K213617.

When was Surgical Face Mask approved by the FDA?

Surgical Face Mask received FDA 510(k) clearance on 2022-02-11, under approval number K213617.

What company makes Surgical Face Mask?

Surgical Face Mask is manufactured by Megasoft (China) Co., Ltd..

What is the FDA product code for Surgical Face Mask?

The FDA product code for Surgical Face Mask is FXX.

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.