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FDA 510(k)

Cardinal Health Nitrile Exam Gloves

K-Number: K241780 · 2024-08-23

ApplicantCardinal Health200, LLC
Decision Date2024-08-23
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Cardinal Health Nitrile Exam Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health200, LLC. It received FDA 510(k) clearance on 2024-08-23 under 510(k) number K241780. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cardinal Health Nitrile Exam Gloves?

Cardinal Health Nitrile Exam Gloves is a medical device that received FDA 510(k) clearance on 2024-08-23. The listed applicant is Cardinal Health200, LLC. The 510(k) number is K241780.

When did Cardinal Health Nitrile Exam Gloves receive FDA 510(k) clearance?

Cardinal Health Nitrile Exam Gloves received FDA 510(k) clearance on 2024-08-23, under 510(k) number K241780.

Who is the listed applicant for Cardinal Health Nitrile Exam Gloves?

The FDA 510(k) record lists Cardinal Health200, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cardinal Health Nitrile Exam Gloves?

The FDA product code for Cardinal Health Nitrile Exam Gloves is LZA.

Other records listing Cardinal Health200, LLC 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.

K230838Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument PocketsK223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)K230028Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing AssemblyK201592Cardinal Health Protexis PI Blue with Neu-Thera Surgical GloveK211390Nitrile Blue Powder-free Examination GloveK200824Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown

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Related Devices (Code: LZA)

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.

K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.K254285Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet BlueHartalega NGC Sdn. Bhd.K252117Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid SolutionSw Technologies, Inc.K253824Powder Free Nitrile Examination Gloves Non-Sterile BlackKanglongda Vietnam Protection Technology Company LimitedK260867Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)Hartalega NGC Sdn. Bhd.K260806Nitrile Disposable Examination GlovesVista Industries,, LLC

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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