FDA 510(k)

Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask

K-Number: K202595 · 2021-01-21

Decision Date2021-01-21

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Premier Guard USA, LLC. It received FDA 510(k) clearance on 2021-01-21 under 510(k) number K202595. 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 Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask?

Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-01-21. The listed applicant is Premier Guard USA, LLC. The 510(k) number is K202595.

When did Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask receive FDA 510(k) clearance?

Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask received FDA 510(k) clearance on 2021-01-21, under 510(k) number K202595.

Who is the listed applicant for Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask?

The FDA 510(k) record lists Premier Guard USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask?

The FDA product code for Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask is FXX.

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Related Devices (Code: 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.