FDA 510(k)

Surgical face mask

K-Number: K211296 · 2021-09-11

ApplicantSunsmed Protective Products , Ltd.

Decision Date2021-09-11

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Surgical face mask is a medical device manufactured by Sunsmed Protective Products , Ltd.. It received FDA 510(k) clearance on 2021-09-11 under approval number K211296. 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 2021-09-11. It is manufactured by Sunsmed Protective Products , Ltd.. The 510(k) number is K211296.

When was Surgical face mask approved by the FDA?

Surgical face mask received FDA 510(k) clearance on 2021-09-11, under approval number K211296.

What company makes Surgical face mask?

Surgical face mask is manufactured by Sunsmed Protective Products , 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

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