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)

ECOMA Level 2 Disposable Surgical Mask with Ear Loops

K-Number: K210698 · 2021-08-19

ApplicantXianning Eco Medical Articles Co., Ltd.
Decision Date2021-08-19
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ECOMA Level 2 Disposable Surgical Mask with Ear Loops is a medical device manufactured by Xianning Eco Medical Articles Co., Ltd.. It received FDA 510(k) clearance on 2021-08-19 under approval number K210698. 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 ECOMA Level 2 Disposable Surgical Mask with Ear Loops?

ECOMA Level 2 Disposable Surgical Mask with Ear Loops is a medical device that received FDA 510(k) clearance on 2021-08-19. It is manufactured by Xianning Eco Medical Articles Co., Ltd.. The 510(k) number is K210698.

When was ECOMA Level 2 Disposable Surgical Mask with Ear Loops approved by the FDA?

ECOMA Level 2 Disposable Surgical Mask with Ear Loops received FDA 510(k) clearance on 2021-08-19, under approval number K210698.

What company makes ECOMA Level 2 Disposable Surgical Mask with Ear Loops?

ECOMA Level 2 Disposable Surgical Mask with Ear Loops is manufactured by Xianning Eco Medical Articles Co., Ltd..

What is the FDA product code for ECOMA Level 2 Disposable Surgical Mask with Ear Loops?

The FDA product code for ECOMA Level 2 Disposable Surgical Mask with Ear Loops is FXX.

Related Clinical Trials

NCT07609888 Photodynamic Therapy as an Adjunct to Non-Surgical Periodontal Therapy in Stage II Periodontitis: A Randomized Split-Mouth Study COMPLETED 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 NCT07580664 Long-term Assessment of BDyn Dynamic Stabilization Device in Patients With Lumbar Degenerative Disc Disease NOT_YET_RECRUITING NCT07524712 Effects of Energy Versus Mechanical Surgical Devices on Postoperative Cough NOT_YET_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)

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.

↑