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FDA 510(k)

Disposable surgical mask

K-Number: K220532 · 2022-05-23

ApplicantXiamen Blue Star Enterprise Co., Ltd.
Decision Date2022-05-23
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable surgical mask is a medical device manufactured by Xiamen Blue Star Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2022-05-23 under approval number K220532. 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 mask?

Disposable surgical mask is a medical device that received FDA 510(k) clearance on 2022-05-23. It is manufactured by Xiamen Blue Star Enterprise Co., Ltd.. The 510(k) number is K220532.

When was Disposable surgical mask approved by the FDA?

Disposable surgical mask received FDA 510(k) clearance on 2022-05-23, under approval number K220532.

What company makes Disposable surgical mask?

Disposable surgical mask is manufactured by Xiamen Blue Star Enterprise Co., Ltd..

What is the FDA product code for Disposable surgical mask?

The FDA product code for Disposable surgical mask 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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