3-Ply Disposable Medical Mask
K-Number: K223045 · 2022-12-07
ApplicantWealth Lead Industrial Limited
Decision Date2022-12-07
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
3-Ply Disposable Medical Mask is a medical device manufactured by Wealth Lead Industrial Limited. It received FDA 510(k) clearance on 2022-12-07 under approval number K223045. 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 3-Ply Disposable Medical Mask?
3-Ply Disposable Medical Mask is a medical device that received FDA 510(k) clearance on 2022-12-07. It is manufactured by Wealth Lead Industrial Limited. The 510(k) number is K223045.
When was 3-Ply Disposable Medical Mask approved by the FDA?
3-Ply Disposable Medical Mask received FDA 510(k) clearance on 2022-12-07, under approval number K223045.
What company makes 3-Ply Disposable Medical Mask?
3-Ply Disposable Medical Mask is manufactured by Wealth Lead Industrial Limited.
What is the FDA product code for 3-Ply Disposable Medical Mask?
The FDA product code for 3-Ply Disposable Medical Mask is 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.