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FDA 510(k)

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

K-Number: K203539 · 2021-12-10

ApplicantUnicoglobal, Inc.
Decision Date2021-12-10
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE) is a medical device manufactured by Unicoglobal, Inc.. It received FDA 510(k) clearance on 2021-12-10 under approval number K203539. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE)?

Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE) is a medical device that received FDA 510(k) clearance on 2021-12-10. It is manufactured by Unicoglobal, Inc.. The 510(k) number is K203539.

When was Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE) approved by the FDA?

Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE) received FDA 510(k) clearance on 2021-12-10, under approval number K203539.

What company makes Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE)?

Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE) is manufactured by Unicoglobal, Inc..

What is the FDA product code for Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE)?

The FDA product code for Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE) is FYA.

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 NCT06744036 Effects of Including Interferential Current in a Therapeutic Exercise Program in Individuals With Knee Osteoarthritis RECRUITING NCT02747485 Impact of Diffuse Myocardial Fibrosis on the Ventricular Function in Regurgitant Left-Sided Valve Heart Diseases ( The DIFFUsE Study) ACTIVE_NOT_RECRUITING NCT07592377 Multicenter Study on the Use of a Collagen-based Hydrogel for the Treatment of 153 Periodontal Pockets in 38 Adults With Generalized Stage III Periodontitis COMPLETED NCT04859725 HyperSpectral Imaging in Low Grade Glioma ACTIVE_NOT_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)

Other Devices by Unicoglobal, Inc.

K210147Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield

Related Devices (Code: FYA)

K162442ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500Gri Medical & Electrical Technology Co., Ltd. K150598Blockade Surgical GownMedline Industries, Inc. K153255Aero Chrome* Breathable Performance Surgical GownHalyard Health, Inc. K172445RoyalGuard Surgical Gown, i600, BreathableGri Medical & Electrical Technology Co., Ltd. K170762Cardinal Health Non-Reinforced Surgical GownCardinal Health200, LLC K162930Aero Chrome* Select Breathable Performance Surgical GownsHalyard Health, Inc.

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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