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FDA 510(k)

Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask

K-Number: K211462 · 2021-08-19

ApplicantXiantao S&J Protective Products Co., Ltd.
Decision Date2021-08-19
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask is a medical device manufactured by Xiantao S&J Protective Products Co., Ltd.. It received FDA 510(k) clearance on 2021-08-19 under approval number K211462. 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 Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask?

Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask is a medical device that received FDA 510(k) clearance on 2021-08-19. It is manufactured by Xiantao S&J Protective Products Co., Ltd.. The 510(k) number is K211462.

When was Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask approved by the FDA?

Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask received FDA 510(k) clearance on 2021-08-19, under approval number K211462.

What company makes Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask?

Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask is manufactured by Xiantao S&J Protective Products Co., Ltd..

What is the FDA product code for Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask?

The FDA product code for Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face 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 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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