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FDA 510(k)

Disposable medical mask

K-Number: K203388 · 2021-06-04

ApplicantEverwin Toys (Dongguan)., Ltd.
Decision Date2021-06-04
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable medical mask is a medical device manufactured by Everwin Toys (Dongguan)., Ltd.. It received FDA 510(k) clearance on 2021-06-04 under approval number K203388. 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 medical mask?

Disposable medical mask is a medical device that received FDA 510(k) clearance on 2021-06-04. It is manufactured by Everwin Toys (Dongguan)., Ltd.. The 510(k) number is K203388.

When was Disposable medical mask approved by the FDA?

Disposable medical mask received FDA 510(k) clearance on 2021-06-04, under approval number K203388.

What company makes Disposable medical mask?

Disposable medical mask is manufactured by Everwin Toys (Dongguan)., Ltd..

What is the FDA product code for Disposable medical mask?

The FDA product code for Disposable medical mask is FXX.

Related Clinical Trials

NCT07273877 "Real-world Assessment of BP Control in Patients With Hypertension by the Netrod RDN System" - REACH-RDN ENROLLING_BY_INVITATION

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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