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FDA 510(k)

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

K-Number: K202595 · 2021-01-21

ApplicantPremier Guard USA, LLC
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 a medical device manufactured by Premier Guard USA, LLC. It received FDA 510(k) clearance on 2021-01-21 under approval 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. It is manufactured by Premier Guard USA, LLC. The 510(k) number is K202595.

When was Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask approved by the FDA?

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

What company makes 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 manufactured by Premier Guard USA, LLC.

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.

Related Clinical Trials

NCT07609888 Photodynamic Therapy as an Adjunct to Non-Surgical Periodontal Therapy in Stage II Periodontitis: A Randomized Split-Mouth Study COMPLETED NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT02747485 Impact of Diffuse Myocardial Fibrosis on the Ventricular Function in Regurgitant Left-Sided Valve Heart Diseases ( The DIFFUsE Study) ACTIVE_NOT_RECRUITING NCT04859725 HyperSpectral Imaging in Low Grade Glioma ACTIVE_NOT_RECRUITING NCT07580664 Long-term Assessment of BDyn Dynamic Stabilization Device in Patients With Lumbar Degenerative Disc Disease NOT_YET_RECRUITING NCT07524712 Effects of Energy Versus Mechanical Surgical Devices on Postoperative Cough NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026)

Related Devices (Code: FXX)

K153409Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC K160269Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd. K152197Skypro, SP01 MaskSkypro Medical Supplies Company K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. K152561Communicator Surgical Facemask with Clear WindowPrestige Ameritech , Ltd. K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap ShieldPrestige Ameritech

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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