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

FDA 510(k)

Disposable Medical Face Masks

K-Number: K202719 · 2021-01-04

Decision Date2021-01-04
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Medical Face Masks is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Sanxin Medtec Co., Ltd.. It received FDA 510(k) clearance on 2021-01-04 under 510(k) number K202719. 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 Medical Face Masks?

Disposable Medical Face Masks is a medical device that received FDA 510(k) clearance on 2021-01-04. The listed applicant is Jiangxi Sanxin Medtec Co., Ltd.. The 510(k) number is K202719.

When did Disposable Medical Face Masks receive FDA 510(k) clearance?

Disposable Medical Face Masks received FDA 510(k) clearance on 2021-01-04, under 510(k) number K202719.

Who is the listed applicant for Disposable Medical Face Masks?

The FDA 510(k) record lists Jiangxi Sanxin Medtec Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Medical Face Masks?

The FDA product code for Disposable Medical Face Masks is FXX.

Other records listing Jiangxi Sanxin Medtec Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: FXX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.