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FDA 510(k)

Surgical Face Mask (Non-sterile)

K-Number: K212398 · 2021-12-15

ApplicantHubei Kimsoul Industrial Co., Ltd.
Decision Date2021-12-15
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Face Mask (Non-sterile) is a medical device manufactured by Hubei Kimsoul Industrial Co., Ltd.. It received FDA 510(k) clearance on 2021-12-15 under approval number K212398. 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 Surgical Face Mask (Non-sterile)?

Surgical Face Mask (Non-sterile) is a medical device that received FDA 510(k) clearance on 2021-12-15. It is manufactured by Hubei Kimsoul Industrial Co., Ltd.. The 510(k) number is K212398.

When was Surgical Face Mask (Non-sterile) approved by the FDA?

Surgical Face Mask (Non-sterile) received FDA 510(k) clearance on 2021-12-15, under approval number K212398.

What company makes Surgical Face Mask (Non-sterile)?

Surgical Face Mask (Non-sterile) is manufactured by Hubei Kimsoul Industrial Co., Ltd..

What is the FDA product code for Surgical Face Mask (Non-sterile)?

The FDA product code for Surgical Face Mask (Non-sterile) 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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