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FDA 510(k)

Disposable Medical Face Masks

K-Number: K202719 · 2021-01-04

ApplicantJiangxi Sanxin Medtec Co., Ltd.
Decision Date2021-01-04
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Medical Face Masks is a medical device manufactured by Jiangxi Sanxin Medtec Co., Ltd.. It received FDA 510(k) clearance on 2021-01-04 under approval 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. It is manufactured by Jiangxi Sanxin Medtec Co., Ltd.. The 510(k) number is K202719.

When was Disposable Medical Face Masks approved by the FDA?

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

What company makes Disposable Medical Face Masks?

Disposable Medical Face Masks is manufactured by Jiangxi Sanxin Medtec Co., Ltd..

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

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

Related Clinical Trials

NCT07060131 Observe the Effects of Far Infrared Eye Masks on Acupoints Around the Eyes in Patients With Dry Eye Syndrome COMPLETED NCT07273877 "Real-world Assessment of BP Control in Patients With Hypertension by the Netrod RDN System" - REACH-RDN ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 30016835 Medical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel. Final order. Federal register (2018)

Other Devices by Jiangxi Sanxin Medtec Co., Ltd.

K202796SANSIN Tubing Sets for Hemodialysis

Related Devices (Code: FXX)

K153409Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC K160269Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd. K152197Skypro, SP01 MaskSkypro Medical Supplies Company K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. K152561Communicator Surgical Facemask with Clear WindowPrestige Ameritech , Ltd. K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap ShieldPrestige Ameritech

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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