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FDA 510(k)

Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield

K-Number: K210147 · 2021-12-22

ApplicantUnicoglobal, Inc.
Decision Date2021-12-22
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield is a medical device manufactured by Unicoglobal, Inc.. It received FDA 510(k) clearance on 2021-12-22 under approval number K210147. 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 Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield?

Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield is a medical device that received FDA 510(k) clearance on 2021-12-22. It is manufactured by Unicoglobal, Inc.. The 510(k) number is K210147.

When was Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield approved by the FDA?

Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield received FDA 510(k) clearance on 2021-12-22, under approval number K210147.

What company makes Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield?

Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield is manufactured by Unicoglobal, Inc..

What is the FDA product code for Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield?

The FDA product code for Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield is FXX.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07607860 Clinical Evaluation of the Adaptilens Accommodating IOL NOT_YET_RECRUITING NCT07470411 Safety and Feasibility of the MACS in Surgical Procedures: A Prospective Multi-Center Study RECRUITING NCT04761120 Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study RECRUITING NCT07185191 Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS) RECRUITING NCT06364865 AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery Study COMPLETED

Other Devices by Unicoglobal, Inc.

K203539Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE)

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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