Secure Wear USA Surgical Face Mask
K-Number: K203101 · 2021-03-31
Decision Date2021-03-31
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Secure Wear USA Surgical Face Mask is a medical device manufactured by Secured Ortho Manufacturing of America, LLC. It received FDA 510(k) clearance on 2021-03-31 under approval number K203101. 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 Secure Wear USA Surgical Face Mask?
Secure Wear USA Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-03-31. It is manufactured by Secured Ortho Manufacturing of America, LLC. The 510(k) number is K203101.
When was Secure Wear USA Surgical Face Mask approved by the FDA?
Secure Wear USA Surgical Face Mask received FDA 510(k) clearance on 2021-03-31, under approval number K203101.
What company makes Secure Wear USA Surgical Face Mask?
Secure Wear USA Surgical Face Mask is manufactured by Secured Ortho Manufacturing of America, LLC.
What is the FDA product code for Secure Wear USA Surgical Face Mask?
The FDA product code for Secure Wear USA 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.