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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 the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health, Inc.. It received FDA 510(k) clearance on 2016-07-25 under 510(k) 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. The listed applicant is Cardinal Health, Inc.. The 510(k) number is K160411.

When did Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating receive FDA 510(k) clearance?

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

Who is the listed applicant for Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating?

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

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 records listing Cardinal Health, Inc. 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.

K221603Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml (B5FD );Kangaroo OMNI™ ENtelliSet 500ml (E5FD );Kangaroo OMNI™ Feeding Set 1000ml (B10FD );Kangaroo OMNI™ ENtelliSet 1000ml (E10FD );Kangaroo OMNI™ ENPlus Spike Set (BSPFD );Kangaroo OMNI™ ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI™ Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI™ ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI™ Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI™K211765Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse GownK170198Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White)K160875Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel CoatingK153316Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)

Related Devices (Code: LYZ)

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.

K260860Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)Basic Medical Technology, Inc.K252467Disposable Vinyl Examination GlovesViet Phu Trade and Import Export Co., Ltd.K252505Powder-Free Vinyl Exam Gloves, clearBasic Medical Technology, Inc.K241252Disposable Vinyl Examination GlovesAnqing Pukang Medical Technology Co., Ltd.K230046Vinyl examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221980Disposable Powder Free Vinyl Examination Gloves, Beige/ClearEver Global (Vietnam) Enterprise Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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