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)

3 Ply Medical Grade Single Use Procedural Disposable Face Mask

K-Number: K220637 · 2022-03-25

ApplicantKdi Med Supply
Decision Date2022-03-25
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

3 Ply Medical Grade Single Use Procedural Disposable Face Mask is a medical device manufactured by Kdi Med Supply. It received FDA 510(k) clearance on 2022-03-25 under approval number K220637. 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 3 Ply Medical Grade Single Use Procedural Disposable Face Mask?

3 Ply Medical Grade Single Use Procedural Disposable Face Mask is a medical device that received FDA 510(k) clearance on 2022-03-25. It is manufactured by Kdi Med Supply. The 510(k) number is K220637.

When was 3 Ply Medical Grade Single Use Procedural Disposable Face Mask approved by the FDA?

3 Ply Medical Grade Single Use Procedural Disposable Face Mask received FDA 510(k) clearance on 2022-03-25, under approval number K220637.

What company makes 3 Ply Medical Grade Single Use Procedural Disposable Face Mask?

3 Ply Medical Grade Single Use Procedural Disposable Face Mask is manufactured by Kdi Med Supply.

What is the FDA product code for 3 Ply Medical Grade Single Use Procedural Disposable Face Mask?

The FDA product code for 3 Ply Medical Grade Single Use Procedural Disposable Face Mask is FXX.

Related Clinical Trials

NCT07611708 Lubricin-inspired Osteoarthritis Treatment: a Unique Solution NOT_YET_RECRUITING NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT01961557 Evaluating a New Knee-Ankle-Foot Brace to Improve Gait in Children With Movement Disorders COMPLETED NCT07614529 Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation NOT_YET_RECRUITING NCT07613658 3D-Printed Versus Band-and-Loop Versus Denovo Space Maintainers in Primary Dentition. NOT_YET_RECRUITING NCT07383870 Clinical Evaluation of an AI- and Ultrasound-Assisted Venipuncture Device COMPLETED

Related PubMed Literature

PMID: 36795788 Regulatory scripting: Stakeholder participation in food and drug administration medical device advisory meetings. PloS one (2023) PMID: 35047938 Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy. Frontiers in medical technology (2021) PMID: 30016835 Medical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel. Final order. Federal register (2018) PMID: 28291189 Orthopaedic Device Approval Through the Premarket Approval Process: A Financial Feasibility Analysis for a Single Center. The Journal of bone and joint surgery. American volume (2017)

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.

↑