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FDA 510(k)

Banded Face Mask

K-Number: K223003 · 2022-11-18

Decision Date2022-11-18
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Banded Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Hubei Medlink Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2022-11-18 under 510(k) 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. The listed applicant is Hubei Medlink Healthcare Co., Ltd.. The 510(k) number is K223003.

When did Banded Face Mask receive FDA 510(k) clearance?

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

Who is the listed applicant for Banded Face Mask?

The FDA 510(k) record lists Hubei Medlink Healthcare Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Banded Face Mask?

The FDA product code for Banded Face Mask is FXX.

Other records listing Hubei Medlink Healthcare Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: FXX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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