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FDA 510(k)

Single-Use Medical Face Mask

K-Number: K210622 · 2021-10-08

ApplicantJiangxi Hongda Medical Equipment Group Co., Ltd.
Decision Date2021-10-08
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Single-Use Medical Face Mask is a medical device manufactured by Jiangxi Hongda Medical Equipment Group Co., Ltd.. It received FDA 510(k) clearance on 2021-10-08 under approval number K210622. 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 Single-Use Medical Face Mask?

Single-Use Medical Face Mask is a medical device that received FDA 510(k) clearance on 2021-10-08. It is manufactured by Jiangxi Hongda Medical Equipment Group Co., Ltd.. The 510(k) number is K210622.

When was Single-Use Medical Face Mask approved by the FDA?

Single-Use Medical Face Mask received FDA 510(k) clearance on 2021-10-08, under approval number K210622.

What company makes Single-Use Medical Face Mask?

Single-Use Medical Face Mask is manufactured by Jiangxi Hongda Medical Equipment Group Co., Ltd..

What is the FDA product code for Single-Use Medical Face Mask?

The FDA product code for Single-Use Medical Face Mask is FXX.

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Related PubMed Literature

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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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