FDA 510(k)

Amerishield Surgical Mask

K-Number: K211520 · 2021-06-15

Decision Date2021-06-15

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Amerishield Surgical Mask is a medical device manufactured by Premiumestore, LLC. It received FDA 510(k) clearance on 2021-06-15 under approval number K211520. 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 Amerishield Surgical Mask?

Amerishield Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-06-15. It is manufactured by Premiumestore, LLC. The 510(k) number is K211520.

When was Amerishield Surgical Mask approved by the FDA?

Amerishield Surgical Mask received FDA 510(k) clearance on 2021-06-15, under approval number K211520.

What company makes Amerishield Surgical Mask?

Amerishield Surgical Mask is manufactured by Premiumestore, LLC.

What is the FDA product code for Amerishield Surgical Mask?

The FDA product code for Amerishield Surgical Mask is FXX.

Other Devices by Premiumestore, LLC

K211275AirMax Procedure Mask

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.