Procedure Mask with Ear Loops and Surgical Mask with Ties

FDA 510(k) K221134 · Safesource Direct, LLC

Substantially Equivalent

510(k) numberK221134

Submission

Device name
Procedure Mask with Ear Loops and Surgical Mask with Ties
Applicant
Safesource Direct, LLC
Broussard, LA, US
Received
April 19, 2022
Decision date
May 19, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
FXX – Mask, Surgical
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4040
Specialty
General, Plastic Surgery

Other 510(k)s with product code FXX

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K252534Surgical Face Mask (Ear mount)FXX · Traditional Zhejiang Hangkang Medical Equipment Co., Ltd.03/03/2026SE
K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)FXX · Special Efofex, Inc.02/19/2026SE
K252830Disposable Surgical Face Mask (3P00B, C2900)FXX · Traditional Beatles Medical Supplies (Xiantao) Co., Ltd.01/12/2026SE
K252650Disposable Medical Face MaskFXX · Traditional Makrite Industries, Inc.01/05/2026SE
K243342KP Protective Face MaskFXX · Traditional Kp Trading Co., Ltd.12/22/2025SE
K252941HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* EarloopsFXX · Traditional O&M Halyard, Inc.12/11/2025SE
K252964PRIMED Surgical and Procedure MasksFXX · Traditional Primed Medical Products, Inc.11/04/2025SE
K251902Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield…FXX · Traditional Vitacore Industries, Inc.09/17/2025SE
K250082Procedure mask/Surgical mask/Face maskFXX · Traditional Winner Medical Co., Ltd.06/18/2025SE

More from Winner Medical Co., Ltd.

510(k)DeviceDecision
K250502SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000…LZA · Special 03/19/2025SE
K222898SafeSource Direct Blue Powder-Free Nitrile Exam GlovesLZA · Traditional 11/07/2022SE

Questions and answers

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

Procedure Mask with Ear Loops and Surgical Mask with Ties (K221134) received a 510(k) decision of Substantially Equivalent on May 19, 2022, 30 days after the submission was received.

What is the product code of K221134?

The FDA product code is FXX – Mask, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.