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FDA 510(k)

Disposable Medical Mask

K-Number: K222545 · 2023-05-19

ApplicantGuangzhou Fuzelong Hygiene Material Co., Ltd.
Decision Date2023-05-19
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 Guangzhou Fuzelong Hygiene Material Co., Ltd.. It received FDA 510(k) clearance on 2023-05-19 under 510(k) number K222545. 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 2023-05-19. The listed applicant is Guangzhou Fuzelong Hygiene Material Co., Ltd.. The 510(k) number is K222545.

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

Disposable Medical Mask received FDA 510(k) clearance on 2023-05-19, under 510(k) number K222545.

Who is the listed applicant for Disposable Medical Mask?

The FDA 510(k) record lists Guangzhou Fuzelong Hygiene Material 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 Guangzhou Fuzelong Hygiene Material 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.

K222403Surgical Gown

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.

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.

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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