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FDA 510(k)

Disposable Medical Face Mask-Model FM-04

K-Number: K202513 · 2021-04-09

ApplicantShenzhen Jinko Industrial Co., Ltd.
Decision Date2021-04-09
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Medical Face Mask-Model FM-04 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Jinko Industrial Co., Ltd.. It received FDA 510(k) clearance on 2021-04-09 under 510(k) number K202513. 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 Disposable Medical Face Mask-Model FM-04?

Disposable Medical Face Mask-Model FM-04 is a medical device that received FDA 510(k) clearance on 2021-04-09. The listed applicant is Shenzhen Jinko Industrial Co., Ltd.. The 510(k) number is K202513.

When did Disposable Medical Face Mask-Model FM-04 receive FDA 510(k) clearance?

Disposable Medical Face Mask-Model FM-04 received FDA 510(k) clearance on 2021-04-09, under 510(k) number K202513.

Who is the listed applicant for Disposable Medical Face Mask-Model FM-04?

The FDA 510(k) record lists Shenzhen Jinko Industrial Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Medical Face Mask-Model FM-04?

The FDA product code for Disposable Medical Face Mask-Model FM-04 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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