Disposable 4 Layers Surgical Face Mask
K-Number: K230093 · 2023-03-02
ApplicantSocial Medical Supply, LLC
Decision Date2023-03-02
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Disposable 4 Layers Surgical Face Mask is a medical device manufactured by Social Medical Supply, LLC. It received FDA 510(k) clearance on 2023-03-02 under approval number K230093. 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 Disposable 4 Layers Surgical Face Mask?
Disposable 4 Layers Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2023-03-02. It is manufactured by Social Medical Supply, LLC. The 510(k) number is K230093.
When was Disposable 4 Layers Surgical Face Mask approved by the FDA?
Disposable 4 Layers Surgical Face Mask received FDA 510(k) clearance on 2023-03-02, under approval number K230093.
What company makes Disposable 4 Layers Surgical Face Mask?
Disposable 4 Layers Surgical Face Mask is manufactured by Social Medical Supply, LLC.
What is the FDA product code for Disposable 4 Layers Surgical Face Mask?
The FDA product code for Disposable 4 Layers Surgical Face 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.