FDA 510(k)

Spin Care Disposable Protective Mask

K-Number: K201624 · 2021-03-18

Decision Date2021-03-18

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Spin Care Disposable Protective Mask is a medical device manufactured by Spintech, LLC. It received FDA 510(k) clearance on 2021-03-18 under approval 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. It is manufactured by Spintech, LLC. The 510(k) number is K201624.

When was Spin Care Disposable Protective Mask approved by the FDA?

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

What company makes Spin Care Disposable Protective Mask?

Spin Care Disposable Protective Mask is manufactured by Spintech, LLC.

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 Devices by Spintech, LLC

K212109Spin Care Disposable Protective Mask Level 3

Related Devices (Code: FXX)

K153409Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC K160269Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd. K152197Skypro, SP01 MaskSkypro Medical Supplies Company K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. K152561Communicator Surgical Facemask with Clear WindowPrestige Ameritech , Ltd. K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap ShieldPrestige Ameritech

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.