Surgical Face Masks (Ear loops and Tie-on)

FDA 510(k) K160269 · San-M Package Co., Ltd.

Substantially Equivalent

510(k) numberK160269

Submission

Device name
Surgical Face Masks (Ear loops and Tie-on)
Applicant
San-M Package Co., Ltd.
Shimada-City, JP
Received
February 2, 2016
Decision date
September 6, 2016
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

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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K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT*…FXX · Traditional O&M Halyard, Inc.03/18/2026SE
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
K221534Surgical Face Masks (Ear Loops And Tie-On)FXX · Traditional 09/16/2022SE
K160271N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12MSH · Abbreviated 07/15/2016SE

Questions and answers

When was Surgical Face Masks (Ear loops and Tie-on) cleared by the FDA?

Surgical Face Masks (Ear loops and Tie-on) (K160269) received a 510(k) decision of Substantially Equivalent on September 6, 2016, 217 days after the submission was received.

What is the product code of K160269?

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