FDA 510(k)

Secure Wear USA Surgical Face Mask

K-Number: K203101 · 2021-03-31

ApplicantSecured Ortho Manufacturing of America, LLC

Decision Date2021-03-31

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Secure Wear USA Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Secured Ortho Manufacturing of America, LLC. It received FDA 510(k) clearance on 2021-03-31 under 510(k) 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. The listed applicant is Secured Ortho Manufacturing of America, LLC. The 510(k) number is K203101.

When did Secure Wear USA Surgical Face Mask receive FDA 510(k) clearance?

Secure Wear USA Surgical Face Mask received FDA 510(k) clearance on 2021-03-31, under 510(k) number K203101.

Who is the listed applicant for Secure Wear USA Surgical Face Mask?

The FDA 510(k) record lists Secured Ortho Manufacturing of America, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.