Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Banded Face Mask

K-Number: K223003 · 2022-11-18

ApplicantHubei Medlink Healthcare Co., Ltd.
Decision Date2022-11-18
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Banded Face Mask is a medical device manufactured by Hubei Medlink Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2022-11-18 under approval number K223003. 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 Banded Face Mask?

Banded Face Mask is a medical device that received FDA 510(k) clearance on 2022-11-18. It is manufactured by Hubei Medlink Healthcare Co., Ltd.. The 510(k) number is K223003.

When was Banded Face Mask approved by the FDA?

Banded Face Mask received FDA 510(k) clearance on 2022-11-18, under approval number K223003.

What company makes Banded Face Mask?

Banded Face Mask is manufactured by Hubei Medlink Healthcare Co., Ltd..

What is the FDA product code for Banded Face Mask?

The FDA product code for Banded Face Mask is FXX.

Other Devices by Hubei Medlink Healthcare Co., Ltd.

K214087Medical Face Mask

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.

↑