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FDA 510(k)

Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating

K-Number: K151778 · 2016-03-24

ApplicantCardinal Health 200, Inc.
Decision Date2016-03-24
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating is a medical device manufactured by Cardinal Health 200, Inc.. It received FDA 510(k) clearance on 2016-03-24 under approval number K151778. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating?

Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating is a medical device that received FDA 510(k) clearance on 2016-03-24. It is manufactured by Cardinal Health 200, Inc.. The 510(k) number is K151778.

When was Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating approved by the FDA?

Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating received FDA 510(k) clearance on 2016-03-24, under approval number K151778.

What company makes Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating?

Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating is manufactured by Cardinal Health 200, Inc..

What is the FDA product code for Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating?

The FDA product code for Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating is KGO.

Related Clinical Trials

NCT06420323 NovoX®Cup as Primary Dressing After Breast Reduction ACTIVE_NOT_RECRUITING NCT07595510 NaviFast 6D for Limb Length Measurement During Total Hip Arthroplasty COMPLETED NCT07372638 Sensorised Surgical Gloves for Neuroendovascular Procedures NOT_YET_RECRUITING NCT04251377 Single-stage Surgery With Antibiotic-loaded Hydrogel Coated Implants Versus Two Stage Surgery for Secondary Prevention of Complex Chronic Periprosthetic Hip Joint Infection ACTIVE_NOT_RECRUITING NCT07212855 Use of Glycine Powder and an Angled Implant Brush in Oral Hygiene Procedures in Patients Rehabilitated With Columbus Bridge Protocol COMPLETED NCT05989750 Air-polishing With Erythritol During Orthodontic Tretament RECRUITING

Related PubMed Literature

PMID: 32944459 Recall Rates of Total Knee Arthroplasty Devices Are Dependent on the FDA Approval Process. Cureus (2020)

Related Devices (Code: KGO)

K160928Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)Hartalega Sdb. Bhd. K160974Gammex Cut-Resistant Glove LinerAnsell Healthcare Products, LLC K161008POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVEHartalega Sdn Bhd K160875Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel CoatingCardinal Health, Inc. K153316Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)Cardinal Health, Inc. K152428SensiCare PI Surgical GlovesMedline Industries, 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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