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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 the device name listed in this FDA 510(k) record. The listed applicant is Unicoglobal, Inc.. It received FDA 510(k) clearance on 2021-12-22 under 510(k) 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. The listed applicant is Unicoglobal, Inc.. The 510(k) number is K210147.

When did Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield receive FDA 510(k) clearance?

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

Who is the listed applicant for Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield?

The FDA 510(k) record lists Unicoglobal, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Unicoglobal, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: FXX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.

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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