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FDA 510(k)

Spin Care Disposable Protective Mask

K-Number: K201624 · 2021-03-18

ApplicantSpintech, LLC
Decision Date2021-03-18
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Spin Care Disposable Protective Mask is the device name listed in this FDA 510(k) record. The listed applicant is Spintech, LLC. It received FDA 510(k) clearance on 2021-03-18 under 510(k) number K201624. 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 Spin Care Disposable Protective Mask?

Spin Care Disposable Protective Mask is a medical device that received FDA 510(k) clearance on 2021-03-18. The listed applicant is Spintech, LLC. The 510(k) number is K201624.

When did Spin Care Disposable Protective Mask receive FDA 510(k) clearance?

Spin Care Disposable Protective Mask received FDA 510(k) clearance on 2021-03-18, under 510(k) number K201624.

Who is the listed applicant for Spin Care Disposable Protective Mask?

The FDA 510(k) record lists Spintech, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spin Care Disposable Protective Mask?

The FDA product code for Spin Care Disposable Protective Mask is FXX.

Other records listing Spintech, LLC 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.

K223079StageK212109Spin Care Disposable Protective Mask Level 3K210843STAGEK173224SPIN-SWI

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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