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FDA 510(k)

Disposable Face Mask

K-Number: K202905 · 2021-03-26

ApplicantJiangsu Excellence Medical Supplies Co., Ltd.
Decision Date2021-03-26
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Excellence Medical Supplies Co., Ltd.. It received FDA 510(k) clearance on 2021-03-26 under 510(k) number K202905. 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 Face Mask?

Disposable Face Mask is a medical device that received FDA 510(k) clearance on 2021-03-26. The listed applicant is Jiangsu Excellence Medical Supplies Co., Ltd.. The 510(k) number is K202905.

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

Disposable Face Mask received FDA 510(k) clearance on 2021-03-26, under 510(k) number K202905.

Who is the listed applicant for Disposable Face Mask?

The FDA 510(k) record lists Jiangsu Excellence Medical Supplies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Face Mask?

The FDA product code for Disposable Face Mask is FXX.

Other records listing Jiangsu Excellence Medical Supplies 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.

K201324Antibacterial Bandage

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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