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FDA 510(k)

GD Disposable Medical Face Mask

K-Number: K201718 · 2021-04-15

ApplicantJiangsu Guangda Medical Material Group Co., Ltd.
Decision Date2021-04-15
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GD Disposable Medical Face Mask is a medical device manufactured by Jiangsu Guangda Medical Material Group Co., Ltd.. It received FDA 510(k) clearance on 2021-04-15 under approval number K201718. 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 GD Disposable Medical Face Mask?

GD Disposable Medical Face Mask is a medical device that received FDA 510(k) clearance on 2021-04-15. It is manufactured by Jiangsu Guangda Medical Material Group Co., Ltd.. The 510(k) number is K201718.

When was GD Disposable Medical Face Mask approved by the FDA?

GD Disposable Medical Face Mask received FDA 510(k) clearance on 2021-04-15, under approval number K201718.

What company makes GD Disposable Medical Face Mask?

GD Disposable Medical Face Mask is manufactured by Jiangsu Guangda Medical Material Group Co., Ltd..

What is the FDA product code for GD Disposable Medical Face Mask?

The FDA product code for GD Disposable Medical Face Mask is FXX.

Related Clinical Trials

NCT07273877 "Real-world Assessment of BP Control in Patients With Hypertension by the Netrod RDN System" - REACH-RDN ENROLLING_BY_INVITATION

Related Devices (Code: FXX)

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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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