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FDA 510(k)

Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs

K-Number: K180646 · 2018-06-27

ApplicantHalyard Health
Decision Date2018-06-27
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs is a medical device manufactured by Halyard Health. It received FDA 510(k) clearance on 2018-06-27 under approval number K180646. 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 Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs?

Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2018-06-27. It is manufactured by Halyard Health. The 510(k) number is K180646.

When was Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs approved by the FDA?

Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2018-06-27, under approval number K180646.

What company makes Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs?

Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs is manufactured by Halyard Health.

What is the FDA product code for Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs?

The FDA product code for Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs is LZC.

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Other Devices by Halyard Health

K161232ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit K160709HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves K153708Halyard Black-Orange Powder-Free Nitrile Exam Glove K181360ON-Q* Pump with Bolus

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

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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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