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)

Protective Face Mask for Medical Use

K-Number: K201537 · 2020-09-04

ApplicantShandong Shengquan New Material Co., Ltd.
Decision Date2020-09-04
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Protective Face Mask for Medical Use is a medical device manufactured by Shandong Shengquan New Material Co., Ltd.. It received FDA 510(k) clearance on 2020-09-04 under approval number K201537. 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 Protective Face Mask for Medical Use?

Protective Face Mask for Medical Use is a medical device that received FDA 510(k) clearance on 2020-09-04. It is manufactured by Shandong Shengquan New Material Co., Ltd.. The 510(k) number is K201537.

When was Protective Face Mask for Medical Use approved by the FDA?

Protective Face Mask for Medical Use received FDA 510(k) clearance on 2020-09-04, under approval number K201537.

What company makes Protective Face Mask for Medical Use?

Protective Face Mask for Medical Use is manufactured by Shandong Shengquan New Material Co., Ltd..

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

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

Related Clinical Trials

NCT07537153 Genicular Artery Embolization for Knee Osteoarthritis RECRUITING NCT06800755 Evaluation of the Efficacy and Tolerance of the Medical Device RL3020-DP0364 in Adult Population With Stable Mild Plaque Psoriasis, Dry Skin and Pruritus COMPLETED NCT07516977 Noseguard for Prevention of Respiratory Infections in Real-World Use NOT_YET_RECRUITING NCT06984484 Performance and Safety of Afluxin® in Patients With Gastroesophageal Reflux Disease RECRUITING NCT06681012 Gelsectan® in the Treatment of Patients With Diarrhoea-predominant Irritable Bowel Syndrome RECRUITING

Other Devices by Shandong Shengquan New Material Co., Ltd.

K201629Medical Face Mask K201514Child Face Mask

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.

↑