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FDA 510(k)

JianYu Surgical Mask

K-Number: K201754 · 2020-12-30

ApplicantJiangsu Jianyu Health Medical Co., Ltd.
Decision Date2020-12-30
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

JianYu Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Jianyu Health Medical Co., Ltd.. It received FDA 510(k) clearance on 2020-12-30 under 510(k) number K201754. 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 JianYu Surgical Mask?

JianYu Surgical Mask is a medical device that received FDA 510(k) clearance on 2020-12-30. The listed applicant is Jiangsu Jianyu Health Medical Co., Ltd.. The 510(k) number is K201754.

When did JianYu Surgical Mask receive FDA 510(k) clearance?

JianYu Surgical Mask received FDA 510(k) clearance on 2020-12-30, under 510(k) number K201754.

Who is the listed applicant for JianYu Surgical Mask?

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

What is the FDA product code for JianYu Surgical Mask?

The FDA product code for JianYu Surgical Mask 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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