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)

TAIJI Professional Series Level 3 Surgical Face Mask

K-Number: K211861 · 2021-07-28

ApplicantTaiji Medical Supplies, Inc.
Decision Date2021-07-28
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TAIJI Professional Series Level 3 Surgical Face Mask is a medical device manufactured by Taiji Medical Supplies, Inc.. It received FDA 510(k) clearance on 2021-07-28 under approval number K211861. 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 TAIJI Professional Series Level 3 Surgical Face Mask?

TAIJI Professional Series Level 3 Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-07-28. It is manufactured by Taiji Medical Supplies, Inc.. The 510(k) number is K211861.

When was TAIJI Professional Series Level 3 Surgical Face Mask approved by the FDA?

TAIJI Professional Series Level 3 Surgical Face Mask received FDA 510(k) clearance on 2021-07-28, under approval number K211861.

What company makes TAIJI Professional Series Level 3 Surgical Face Mask?

TAIJI Professional Series Level 3 Surgical Face Mask is manufactured by Taiji Medical Supplies, Inc..

What is the FDA product code for TAIJI Professional Series Level 3 Surgical Face Mask?

The FDA product code for TAIJI Professional Series Level 3 Surgical Face Mask is FXX.

Related Clinical Trials

NCT07607457 Development and Evaluation of the Effectiveness of Patient Gowns for Patients Undergoing Abdominal Surgery NOT_YET_RECRUITING NCT07609888 Photodynamic Therapy as an Adjunct to Non-Surgical Periodontal Therapy in Stage II Periodontitis: A Randomized Split-Mouth Study COMPLETED NCT06915012 Impact of Biophoton Therapy on Chronic Severe Arthritis Pain RECRUITING NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT02747485 Impact of Diffuse Myocardial Fibrosis on the Ventricular Function in Regurgitant Left-Sided Valve Heart Diseases ( The DIFFUsE Study) ACTIVE_NOT_RECRUITING NCT04859725 HyperSpectral Imaging in Low Grade Glioma ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41322758 Real-World Case Series on Surgi-ORC® in ENT Surgery. Cureus (2025)

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.

↑