Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove

FDA 510(k) K201592 · Cardinal Health200, LLC

Substantially Equivalent

510(k) numberK201592

Submission

Device name
Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove
Applicant
Cardinal Health200, LLC
Waukegan, IL, US
Received
June 12, 2020
Decision date
September 26, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KGO – Surgeon'S Gloves
Device class
Class I (low risk)
Regulation
21 CFR 878.4460
Specialty
General, Plastic Surgery

A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

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K260558Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl…KGO · Traditional Hartalega NGC Sdn. Bhd.07/28/2026SE
K253060Sterile Latex Powder Free Surgical GlovesKGO · Traditional Protect Gloves Company Limited05/22/2026SE
K250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With…KGO · Abbreviated Harps Europe Manufacturing GmbH08/19/2025SE
K240790Polyisoprene Surgical glovesKGO · Traditional Suzhou Colour-Way New Material Co., Ltd.08/23/2024SE
K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with…KGO · Traditional Wrp Asia Pacific Sdn. Bhd.03/28/2024SE
K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsKGO · Traditional Grand Work Plastic Products Co., Ltd.12/20/2023SE
K231902GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid…KGO · Traditional Ansell Healthcare10/20/2023SE
K231973PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical GloveKGO · Traditional Ineo Tech Sdn Bhd09/29/2023SE
K231446Single-Use Latex Sterile Surgical Gloves (SG100)KGO · Traditional Fitone Latex Products Co., Ltd. Guangdong09/22/2023SE
K230578Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with…KGO · Traditional Wrp Asia Pacific Sdn. Bhd.08/31/2023SE

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K230028Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express…JOW · Traditional 04/03/2023SE
K211390Nitrile Blue Powder-free Examination GloveLZA · Traditional 08/28/2021SE
K200824Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR…FYA · Traditional 07/29/2020SE
K193327Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus…FYA · Traditional 03/20/2020SE
K192374Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam StripFXX · Traditional 12/02/2019SE
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Questions and answers

When was Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove cleared by the FDA?

Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove (K201592) received a 510(k) decision of Substantially Equivalent on September 26, 2021, 471 days after the submission was received.

What is the product code of K201592?

The FDA product code is KGO – Surgeon'S Gloves, a Class I (low risk) device regulated under 21 CFR 878.4460.