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FDA 510(k)

Cardinal Health Nitrile Examination Gloves Extended Cuff

K-Number: K252313 · 2026-01-14

ApplicantCardinalhealth
Decision Date2026-01-14
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Cardinal Health Nitrile Examination Gloves Extended Cuff is a medical device manufactured by Cardinalhealth. It received FDA 510(k) clearance on 2026-01-14 under approval number K252313. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cardinal Health Nitrile Examination Gloves Extended Cuff?

Cardinal Health Nitrile Examination Gloves Extended Cuff is a medical device that received FDA 510(k) clearance on 2026-01-14. It is manufactured by Cardinalhealth. The 510(k) number is K252313.

When was Cardinal Health Nitrile Examination Gloves Extended Cuff approved by the FDA?

Cardinal Health Nitrile Examination Gloves Extended Cuff received FDA 510(k) clearance on 2026-01-14, under approval number K252313.

What company makes Cardinal Health Nitrile Examination Gloves Extended Cuff?

Cardinal Health Nitrile Examination Gloves Extended Cuff is manufactured by Cardinalhealth.

What is the FDA product code for Cardinal Health Nitrile Examination Gloves Extended Cuff?

The FDA product code for Cardinal Health Nitrile Examination Gloves Extended Cuff is LZC.

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Related PubMed Literature

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Related Devices (Code: LZC)

K160709HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health K151390Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy DrugsMaxter Glove Manufacturing Sdn Bhd K152222NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy DrugsGmp Medicare Sdn Bhd (F25) K172642Orange Non Sterile Powder Free Nitrile Examination GlovesCentral Medicare Sdn Bhd K172525Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy DrugsCentral Medicare Sdn Bhd K162858NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTESTCareplus (M) Sdn Bhd

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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