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)

Standard Procedure Mask, Standard Surgical Mask

K-Number: K202605 · 2021-02-10

Decision Date2021-02-10
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Standard Procedure Mask, Standard Surgical Mask is a medical device manufactured by Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.. It received FDA 510(k) clearance on 2021-02-10 under approval number K202605. 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 Standard Procedure Mask, Standard Surgical Mask?

Standard Procedure Mask, Standard Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-02-10. It is manufactured by Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.. The 510(k) number is K202605.

When was Standard Procedure Mask, Standard Surgical Mask approved by the FDA?

Standard Procedure Mask, Standard Surgical Mask received FDA 510(k) clearance on 2021-02-10, under approval number K202605.

What company makes Standard Procedure Mask, Standard Surgical Mask?

Standard Procedure Mask, Standard Surgical Mask is manufactured by Jiangsu Medplus Non-Woven Manufacturer Co., Ltd..

What is the FDA product code for Standard Procedure Mask, Standard Surgical Mask?

The FDA product code for Standard Procedure Mask, Standard Surgical Mask is FXX.

Related Clinical Trials

Related PubMed Literature

Other Devices by Jiangsu Medplus Non-Woven Manufacturer 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.