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FDA 510(k)

Procedure Mask, Surgical Mask

K-Number: K213001 · 2022-05-11

ApplicantA Plus International, Inc.
Decision Date2022-05-11
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Procedure Mask, Surgical Mask is a medical device manufactured by A Plus International, Inc.. It received FDA 510(k) clearance on 2022-05-11 under approval number K213001. 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 Procedure Mask, Surgical Mask?

Procedure Mask, Surgical Mask is a medical device that received FDA 510(k) clearance on 2022-05-11. It is manufactured by A Plus International, Inc.. The 510(k) number is K213001.

When was Procedure Mask, Surgical Mask approved by the FDA?

Procedure Mask, Surgical Mask received FDA 510(k) clearance on 2022-05-11, under approval number K213001.

What company makes Procedure Mask, Surgical Mask?

Procedure Mask, Surgical Mask is manufactured by A Plus International, Inc..

What is the FDA product code for Procedure Mask, Surgical Mask?

The FDA product code for Procedure Mask, Surgical Mask is FXX.

Related Clinical Trials

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Related PubMed Literature

PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

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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