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FDA 510(k)

Surgical Face Mask (Tie on/ Ear loops)

K-Number: K240916 · 2024-10-18

ApplicantXiantao Daoqi Plastic Co., Ltd.
Decision Date2024-10-18
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Face Mask (Tie on/ Ear loops) is the device name listed in this FDA 510(k) record. The listed applicant is Xiantao Daoqi Plastic Co., Ltd.. It received FDA 510(k) clearance on 2024-10-18 under 510(k) number K240916. 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 Surgical Face Mask (Tie on/ Ear loops)?

Surgical Face Mask (Tie on/ Ear loops) is a medical device that received FDA 510(k) clearance on 2024-10-18. The listed applicant is Xiantao Daoqi Plastic Co., Ltd.. The 510(k) number is K240916.

When did Surgical Face Mask (Tie on/ Ear loops) receive FDA 510(k) clearance?

Surgical Face Mask (Tie on/ Ear loops) received FDA 510(k) clearance on 2024-10-18, under 510(k) number K240916.

Who is the listed applicant for Surgical Face Mask (Tie on/ Ear loops)?

The FDA 510(k) record lists Xiantao Daoqi Plastic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Face Mask (Tie on/ Ear loops)?

The FDA product code for Surgical Face Mask (Tie on/ Ear loops) is FXX.

Related Devices (Code: FXX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.

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