FDA 510(k)

ECOMA Level 2 Disposable Surgical Mask with Ear Loops

K-Number: K210698 · 2021-08-19

ApplicantXianning Eco Medical Articles Co., Ltd.

Decision Date2021-08-19

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ECOMA Level 2 Disposable Surgical Mask with Ear Loops is the device name listed in this FDA 510(k) record. The listed applicant is Xianning Eco Medical Articles Co., Ltd.. It received FDA 510(k) clearance on 2021-08-19 under 510(k) number K210698. 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 ECOMA Level 2 Disposable Surgical Mask with Ear Loops?

ECOMA Level 2 Disposable Surgical Mask with Ear Loops is a medical device that received FDA 510(k) clearance on 2021-08-19. The listed applicant is Xianning Eco Medical Articles Co., Ltd.. The 510(k) number is K210698.

When did ECOMA Level 2 Disposable Surgical Mask with Ear Loops receive FDA 510(k) clearance?

ECOMA Level 2 Disposable Surgical Mask with Ear Loops received FDA 510(k) clearance on 2021-08-19, under 510(k) number K210698.

Who is the listed applicant for ECOMA Level 2 Disposable Surgical Mask with Ear Loops?

The FDA 510(k) record lists Xianning Eco Medical Articles Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECOMA Level 2 Disposable Surgical Mask with Ear Loops?

The FDA product code for ECOMA Level 2 Disposable Surgical Mask with Ear Loops is FXX.

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Related Devices (Code: FXX)

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.