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FDA 510(k)

Paneffort 3-ply Surgical and Procedural Masks

K-Number: K221409 · 2022-07-25

ApplicantPaneffort, LLC
Decision Date2022-07-25
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Paneffort 3-ply Surgical and Procedural Masks is a medical device manufactured by Paneffort, LLC. It received FDA 510(k) clearance on 2022-07-25 under approval number K221409. 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 Paneffort 3-ply Surgical and Procedural Masks?

Paneffort 3-ply Surgical and Procedural Masks is a medical device that received FDA 510(k) clearance on 2022-07-25. It is manufactured by Paneffort, LLC. The 510(k) number is K221409.

When was Paneffort 3-ply Surgical and Procedural Masks approved by the FDA?

Paneffort 3-ply Surgical and Procedural Masks received FDA 510(k) clearance on 2022-07-25, under approval number K221409.

What company makes Paneffort 3-ply Surgical and Procedural Masks?

Paneffort 3-ply Surgical and Procedural Masks is manufactured by Paneffort, LLC.

What is the FDA product code for Paneffort 3-ply Surgical and Procedural Masks?

The FDA product code for Paneffort 3-ply Surgical and Procedural Masks is FXX.

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Other Devices by Paneffort, LLC

K212717Paneffort AAMI Level 3 Isolation Gown

Related Devices (Code: FXX)

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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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