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FDA 510(k)

Disposable Medical Face Mask (ear loop)

K-Number: K221196 · 2022-07-22

ApplicantXiantao Topmed Nonwoven Protective Products Co., Ltd.
Decision Date2022-07-22
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Medical Face Mask (ear loop) is a medical device manufactured by Xiantao Topmed Nonwoven Protective Products Co., Ltd.. It received FDA 510(k) clearance on 2022-07-22 under approval number K221196. 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 Face Mask (ear loop)?

Disposable Medical Face Mask (ear loop) is a medical device that received FDA 510(k) clearance on 2022-07-22. It is manufactured by Xiantao Topmed Nonwoven Protective Products Co., Ltd.. The 510(k) number is K221196.

When was Disposable Medical Face Mask (ear loop) approved by the FDA?

Disposable Medical Face Mask (ear loop) received FDA 510(k) clearance on 2022-07-22, under approval number K221196.

What company makes Disposable Medical Face Mask (ear loop)?

Disposable Medical Face Mask (ear loop) is manufactured by Xiantao Topmed Nonwoven Protective Products Co., Ltd..

What is the FDA product code for Disposable Medical Face Mask (ear loop)?

The FDA product code for Disposable Medical Face Mask (ear loop) 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)

Other Devices by Xiantao Topmed Nonwoven Protective Products Co., Ltd.

K221977Disposable Surgical Gown (G4003)

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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