FDA 510(k)

Sparta 3-Ply Surgical Disposable Face Mask

K-Number: K220378 · 2022-06-30

Decision Date2022-06-30

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Sparta 3-Ply Surgical Disposable Face Mask is a medical device manufactured by Sparta East, LLC. It received FDA 510(k) clearance on 2022-06-30 under approval number K220378. 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 Sparta 3-Ply Surgical Disposable Face Mask?

Sparta 3-Ply Surgical Disposable Face Mask is a medical device that received FDA 510(k) clearance on 2022-06-30. It is manufactured by Sparta East, LLC. The 510(k) number is K220378.

When was Sparta 3-Ply Surgical Disposable Face Mask approved by the FDA?

Sparta 3-Ply Surgical Disposable Face Mask received FDA 510(k) clearance on 2022-06-30, under approval number K220378.

What company makes Sparta 3-Ply Surgical Disposable Face Mask?

Sparta 3-Ply Surgical Disposable Face Mask is manufactured by Sparta East, LLC.

What is the FDA product code for Sparta 3-Ply Surgical Disposable Face Mask?

The FDA product code for Sparta 3-Ply Surgical Disposable 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.