STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING— 510(k) K113707

Clearance details

Applicant

Cardinal Health-Medical Products and Services

Product code

Code KGO

Device class

Class 1

Regulation

21 CFR 878.4460

Advisory panel

General, Plastic Surgery

Date received

2011-12-16

Decision date

2012-04-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Waukegan, IL, US

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• Z-0631-2019 — Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.Class II·Terminated·Cardinal Health 200, LLC·20181031
• Z-0632-2019 — Protexis Neoprene Surgical Glove, Size 6.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.Class II·Terminated·Cardinal Health 200, LLC·20181031
• Z-0633-2019 — Protexis Neoprene Surgical Glove, Size 6.5 This powder-free Surgeon s glovessterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.Class II·Terminated·Cardinal Health 200, LLC·20181031
• Z-0634-2019 — Protexis Neoprene Surgical Glove, Size 7.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.Class II·Terminated·Cardinal Health 200, LLC·20181031
• Z-0635-2019 — Protexis Neoprene Surgical Glove, Size 7.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.Class II·Terminated·Cardinal Health 200, LLC·20181031
• Z-0636-2019 — Protexis Neoprene Surgical Glove, Size 8.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.Class II·Terminated·Cardinal Health 200, LLC·20181031
• Z-0637-2019 — Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.Class II·Terminated·Cardinal Health 200, LLC·20181031
• Z-0638-2019 — Protexis Neoprene Surgical Glove, Size 9.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.Class II·Terminated·Cardinal Health 200, LLC·20181031

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113707.