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)

Procedure Mask with Ear Loops and Surgical Mask with Ties

K-Number: K221134 · 2022-05-19

ApplicantSafesource Direct, LLC
Decision Date2022-05-19
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Procedure Mask with Ear Loops and Surgical Mask with Ties is a medical device manufactured by Safesource Direct, LLC. It received FDA 510(k) clearance on 2022-05-19 under approval number K221134. 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 Procedure Mask with Ear Loops and Surgical Mask with Ties?

Procedure Mask with Ear Loops and Surgical Mask with Ties is a medical device that received FDA 510(k) clearance on 2022-05-19. It is manufactured by Safesource Direct, LLC. The 510(k) number is K221134.

When was Procedure Mask with Ear Loops and Surgical Mask with Ties approved by the FDA?

Procedure Mask with Ear Loops and Surgical Mask with Ties received FDA 510(k) clearance on 2022-05-19, under approval number K221134.

What company makes Procedure Mask with Ear Loops and Surgical Mask with Ties?

Procedure Mask with Ear Loops and Surgical Mask with Ties is manufactured by Safesource Direct, LLC.

What is the FDA product code for Procedure Mask with Ear Loops and Surgical Mask with Ties?

The FDA product code for Procedure Mask with Ear Loops and Surgical Mask with Ties is FXX.

Related Clinical Trials

NCT07175129 Transverse Tibial Transport for Chronic Limb-Threatening Ischemia (CLTI) WITHDRAWN NCT07202312 Ozone-therapy in Non-surgical Periodontal Therapy COMPLETED NCT07609888 Photodynamic Therapy as an Adjunct to Non-Surgical Periodontal Therapy in Stage II Periodontitis: A Randomized Split-Mouth Study COMPLETED NCT07607366 Effects of Negative Pressure Wound Bandaging After Mastectomy RECRUITING NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT07605286 Soft Tissue Augmentation Around Dental Implants COMPLETED

Related PubMed Literature

PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by Safesource Direct, LLC

K222898SafeSource Direct Blue Powder-Free Nitrile Exam Gloves K250502SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000)

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.

↑