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FDA 510(k)

Disposable Surgical Mask (Model: YYKZ-01)

K-Number: K210845 · 2021-10-12

ApplicantJiaxing Amazing Travel-Ware Co., Ltd.
Decision Date2021-10-12
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Surgical Mask (Model: YYKZ-01) is a medical device manufactured by Jiaxing Amazing Travel-Ware Co., Ltd.. It received FDA 510(k) clearance on 2021-10-12 under approval number K210845. 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 Surgical Mask (Model: YYKZ-01)?

Disposable Surgical Mask (Model: YYKZ-01) is a medical device that received FDA 510(k) clearance on 2021-10-12. It is manufactured by Jiaxing Amazing Travel-Ware Co., Ltd.. The 510(k) number is K210845.

When was Disposable Surgical Mask (Model: YYKZ-01) approved by the FDA?

Disposable Surgical Mask (Model: YYKZ-01) received FDA 510(k) clearance on 2021-10-12, under approval number K210845.

What company makes Disposable Surgical Mask (Model: YYKZ-01)?

Disposable Surgical Mask (Model: YYKZ-01) is manufactured by Jiaxing Amazing Travel-Ware Co., Ltd..

What is the FDA product code for Disposable Surgical Mask (Model: YYKZ-01)?

The FDA product code for Disposable Surgical Mask (Model: YYKZ-01) is FXX.

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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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