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FDA 510(k)

Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating

K-Number: K160411 · 2016-07-25

ApplicantCardinal Health, Inc.
Decision Date2016-07-25
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating is a medical device manufactured by Cardinal Health, Inc.. It received FDA 510(k) clearance on 2016-07-25 under approval number K160411. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating?

Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating is a medical device that received FDA 510(k) clearance on 2016-07-25. It is manufactured by Cardinal Health, Inc.. The 510(k) number is K160411.

When was Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating approved by the FDA?

Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating received FDA 510(k) clearance on 2016-07-25, under approval number K160411.

What company makes Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating?

Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating is manufactured by Cardinal Health, Inc..

What is the FDA product code for Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating?

The FDA product code for Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating is LYZ.

Other Devices by Cardinal Health, Inc.

K160875Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating K153316Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow) K170198Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White)

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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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