FDA 510(k)

PMW01 Procedure Mask Level 1

K-Number: K211772 · 2021-12-06

Decision Date2021-12-06

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PMW01 Procedure Mask Level 1 is a medical device manufactured by Defender Safety, Inc.. It received FDA 510(k) clearance on 2021-12-06 under approval number K211772. 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 PMW01 Procedure Mask Level 1?

PMW01 Procedure Mask Level 1 is a medical device that received FDA 510(k) clearance on 2021-12-06. It is manufactured by Defender Safety, Inc.. The 510(k) number is K211772.

When was PMW01 Procedure Mask Level 1 approved by the FDA?

PMW01 Procedure Mask Level 1 received FDA 510(k) clearance on 2021-12-06, under approval number K211772.

What company makes PMW01 Procedure Mask Level 1?

PMW01 Procedure Mask Level 1 is manufactured by Defender Safety, Inc..

What is the FDA product code for PMW01 Procedure Mask Level 1?

The FDA product code for PMW01 Procedure Mask Level 1 is FXX.

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Other Devices by Defender Safety, Inc.

K210705Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical 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.