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FDA 510(k)

HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves

K-Number: K160709 · 2016-09-06

ApplicantHalyard Health
Decision Date2016-09-06
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves is a medical device manufactured by Halyard Health. It received FDA 510(k) clearance on 2016-09-06 under approval number K160709. 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* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves?

HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves is a medical device that received FDA 510(k) clearance on 2016-09-06. It is manufactured by Halyard Health. The 510(k) number is K160709.

When was HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves approved by the FDA?

HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves received FDA 510(k) clearance on 2016-09-06, under approval number K160709.

What company makes HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves?

HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves is manufactured by Halyard Health.

What is the FDA product code for HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves?

The FDA product code for HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves is LZC.

Other Devices by Halyard Health

K161232ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit K153708Halyard Black-Orange Powder-Free Nitrile Exam Glove K180646Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs K181360ON-Q* Pump with Bolus

Related Devices (Code: LZC)

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 K162186BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIMBrightway Holdings 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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