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FDA 510(k)

Altor Safety 4-Ply Surgical Mask (Model:62232)

K-Number: K211762 · 2021-09-03

ApplicantAltor Safety, LLC
Decision Date2021-09-03
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Altor Safety 4-Ply Surgical Mask (Model:62232) is a medical device manufactured by Altor Safety, LLC. It received FDA 510(k) clearance on 2021-09-03 under approval number K211762. 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 Altor Safety 4-Ply Surgical Mask (Model:62232)?

Altor Safety 4-Ply Surgical Mask (Model:62232) is a medical device that received FDA 510(k) clearance on 2021-09-03. It is manufactured by Altor Safety, LLC. The 510(k) number is K211762.

When was Altor Safety 4-Ply Surgical Mask (Model:62232) approved by the FDA?

Altor Safety 4-Ply Surgical Mask (Model:62232) received FDA 510(k) clearance on 2021-09-03, under approval number K211762.

What company makes Altor Safety 4-Ply Surgical Mask (Model:62232)?

Altor Safety 4-Ply Surgical Mask (Model:62232) is manufactured by Altor Safety, LLC.

What is the FDA product code for Altor Safety 4-Ply Surgical Mask (Model:62232)?

The FDA product code for Altor Safety 4-Ply Surgical Mask (Model:62232) is FXX.

Related Clinical Trials

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Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 41322758 Real-World Case Series on Surgi-ORC® in ENT Surgery. Cureus (2025) PMID: 40856794 [Translational challenges and clinical potential of artificial intelligence in minimally invasive surgery]. Chirurgie (Heidelberg, Germany) (2025)

Other Devices by Altor Safety, LLC

K211249Altor Safety 3-Ply Surgical Mask (Model:62222)

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

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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