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FDA 510(k)

Disposable Medical mask

K-Number: K210150 · 2021-06-02

Decision Date2021-06-02
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Medical mask is the device name listed in this FDA 510(k) record. The listed applicant is Hubei Wanli Protective Products Co., Ltd.. It received FDA 510(k) clearance on 2021-06-02 under 510(k) number K210150. 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 mask?

Disposable Medical mask is a medical device that received FDA 510(k) clearance on 2021-06-02. The listed applicant is Hubei Wanli Protective Products Co., Ltd.. The 510(k) number is K210150.

When did Disposable Medical mask receive FDA 510(k) clearance?

Disposable Medical mask received FDA 510(k) clearance on 2021-06-02, under 510(k) number K210150.

Who is the listed applicant for Disposable Medical mask?

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

What is the FDA product code for Disposable Medical mask?

The FDA product code for Disposable Medical mask is FXX.

Other records listing Hubei Wanli Protective Products 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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.