Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Face Mask

K-Number: K210007 · 2021-04-23

Decision Date2021-04-23
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Face Mask is a medical device manufactured by Jinhua Jingdi Medical Supplies Co., Ltd.. It received FDA 510(k) clearance on 2021-04-23 under approval number K210007. 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 Face Mask?

Face Mask is a medical device that received FDA 510(k) clearance on 2021-04-23. It is manufactured by Jinhua Jingdi Medical Supplies Co., Ltd.. The 510(k) number is K210007.

When was Face Mask approved by the FDA?

Face Mask received FDA 510(k) clearance on 2021-04-23, under approval number K210007.

What company makes Face Mask?

Face Mask is manufactured by Jinhua Jingdi Medical Supplies Co., Ltd..

What is the FDA product code for Face Mask?

The FDA product code for Face Mask is FXX.

Other Devices by Jinhua Jingdi Medical Supplies Co., Ltd.

Related Devices (Code: FXX)

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.