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)

Altor Safety 3-Ply Surgical Mask (Model:62222)

K-Number: K211249 · 2021-07-23

ApplicantAltor Safety, LLC
Decision Date2021-07-23
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Altor Safety 3-Ply Surgical Mask (Model:62222) is a medical device manufactured by Altor Safety, LLC. It received FDA 510(k) clearance on 2021-07-23 under approval number K211249. 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 Altor Safety 3-Ply Surgical Mask (Model:62222)?

Altor Safety 3-Ply Surgical Mask (Model:62222) is a medical device that received FDA 510(k) clearance on 2021-07-23. It is manufactured by Altor Safety, LLC. The 510(k) number is K211249.

When was Altor Safety 3-Ply Surgical Mask (Model:62222) approved by the FDA?

Altor Safety 3-Ply Surgical Mask (Model:62222) received FDA 510(k) clearance on 2021-07-23, under approval number K211249.

What company makes Altor Safety 3-Ply Surgical Mask (Model:62222)?

Altor Safety 3-Ply Surgical Mask (Model:62222) is manufactured by Altor Safety, LLC.

What is the FDA product code for Altor Safety 3-Ply Surgical Mask (Model:62222)?

The FDA product code for Altor Safety 3-Ply Surgical Mask (Model:62222) is FXX.

Related Clinical Trials

NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07607860 Clinical Evaluation of the Adaptilens Accommodating IOL NOT_YET_RECRUITING NCT07611474 To Evaluate the Safety and Effectiveness of Intrauterine Adhesion Preventer in the Prevention and Treatment of Intrauterine Adhesions, a Prospective, Multicenter, Randomized Controlled Clinical Trial RECRUITING NCT07607457 Development and Evaluation of the Effectiveness of Patient Gowns for Patients Undergoing Abdominal Surgery NOT_YET_RECRUITING NCT07606430 Comparison of a Short Modified Metal Stent Versus Plastic Stent as a Bridge to Surgery in Pancreatic Cancer With Malignant Biliary Obstruction NOT_YET_RECRUITING NCT05526560 Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 36103178 Estimated Cost of Developing a Therapeutic Complex Medical Device in the US. JAMA network open (2022) PMID: 25646114 Transcatheter valve therapy registry is a model for medical device innovation and surveillance. Health affairs (Project Hope) (2015)

Other Devices by Altor Safety, LLC

K211762Altor Safety 4-Ply Surgical Mask (Model:62232)

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.

↑