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FDA 510(k)

PMW01 Procedure Mask Level 1

K-Number: K211772 · 2021-12-06

ApplicantDefender Safety, Inc.
Decision Date2021-12-06
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PMW01 Procedure Mask Level 1 is the device name listed in this FDA 510(k) record. The listed applicant is Defender Safety, Inc.. It received FDA 510(k) clearance on 2021-12-06 under 510(k) 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. The listed applicant is Defender Safety, Inc.. The 510(k) number is K211772.

When did PMW01 Procedure Mask Level 1 receive FDA 510(k) clearance?

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

Who is the listed applicant for PMW01 Procedure Mask Level 1?

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

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

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

Other records listing Defender Safety, Inc. 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.

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

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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