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FDA 510(k)

3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)

K-Number: K210772 · 2021-09-22

ApplicantVr Vertical, LLC Dba Xrgo
Decision Date2021-09-22
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT) is a medical device manufactured by Vr Vertical, LLC Dba Xrgo. It received FDA 510(k) clearance on 2021-09-22 under approval number K210772. 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-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)?

3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT) is a medical device that received FDA 510(k) clearance on 2021-09-22. It is manufactured by Vr Vertical, LLC Dba Xrgo. The 510(k) number is K210772.

When was 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT) approved by the FDA?

3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT) received FDA 510(k) clearance on 2021-09-22, under approval number K210772.

What company makes 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)?

3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT) is manufactured by Vr Vertical, LLC Dba Xrgo.

What is the FDA product code for 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)?

The FDA product code for 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT) is FXX.

Related Clinical Trials

NCT07060131 Observe the Effects of Far Infrared Eye Masks on Acupoints Around the Eyes in Patients With Dry Eye Syndrome COMPLETED NCT06636136 Transtibial Osseointegration RECRUITING

Related PubMed Literature

PMID: 40440607 Regulating the future of laboratory medicine: European regulatory landscape of AI-driven medical device software in laboratory medicine. Clinical chemistry and laboratory 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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