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FDA 510(k)

Disposable Surgical Face Mask (FM-34EE,FM-44EE)

K-Number: K220597 · 2022-05-26

ApplicantQingdao Bestex Rubber & Plastic Products Co., Ltd.
Decision Date2022-05-26
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Surgical Face Mask (FM-34EE,FM-44EE) is a medical device manufactured by Qingdao Bestex Rubber & Plastic Products Co., Ltd.. It received FDA 510(k) clearance on 2022-05-26 under approval number K220597. 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 Disposable Surgical Face Mask (FM-34EE,FM-44EE)?

Disposable Surgical Face Mask (FM-34EE,FM-44EE) is a medical device that received FDA 510(k) clearance on 2022-05-26. It is manufactured by Qingdao Bestex Rubber & Plastic Products Co., Ltd.. The 510(k) number is K220597.

When was Disposable Surgical Face Mask (FM-34EE,FM-44EE) approved by the FDA?

Disposable Surgical Face Mask (FM-34EE,FM-44EE) received FDA 510(k) clearance on 2022-05-26, under approval number K220597.

What company makes Disposable Surgical Face Mask (FM-34EE,FM-44EE)?

Disposable Surgical Face Mask (FM-34EE,FM-44EE) is manufactured by Qingdao Bestex Rubber & Plastic Products Co., Ltd..

What is the FDA product code for Disposable Surgical Face Mask (FM-34EE,FM-44EE)?

The FDA product code for Disposable Surgical Face Mask (FM-34EE,FM-44EE) is FXX.

Related PubMed Literature

PMID: 30016835 Medical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel. Final order. Federal register (2018)

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.

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