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FDA 510(k)

Protective Face Mask for Medical Use

K-Number: K201537 · 2020-09-04

ApplicantShandong Shengquan New Material Co., Ltd.
Decision Date2020-09-04
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Protective Face Mask for Medical Use is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Shengquan New Material Co., Ltd.. It received FDA 510(k) clearance on 2020-09-04 under 510(k) number K201537. 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 Protective Face Mask for Medical Use?

Protective Face Mask for Medical Use is a medical device that received FDA 510(k) clearance on 2020-09-04. The listed applicant is Shandong Shengquan New Material Co., Ltd.. The 510(k) number is K201537.

When did Protective Face Mask for Medical Use receive FDA 510(k) clearance?

Protective Face Mask for Medical Use received FDA 510(k) clearance on 2020-09-04, under 510(k) number K201537.

Who is the listed applicant for Protective Face Mask for Medical Use?

The FDA 510(k) record lists Shandong Shengquan New Material Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Protective Face Mask for Medical Use?

The FDA product code for Protective Face Mask for Medical Use is FXX.

Other records listing Shandong Shengquan New Material Co., Ltd. as applicant

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.

K201514Child Face MaskK201629Medical Face Mask

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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