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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 the device name listed in this FDA 510(k) record. The listed applicant is Halyard Health. It received FDA 510(k) clearance on 2016-09-06 under 510(k) 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. The listed applicant is Halyard Health. The 510(k) number is K160709.

When did HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves receive FDA 510(k) clearance?

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

Who is the listed applicant for HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves?

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

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 records listing Halyard Health as applicant

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Related Devices (Code: LZC)

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.

K252313Cardinal Health Nitrile Examination Gloves Extended CuffCardinalhealthK243959Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other DrugsLingshi Hongruida Health Protection Technology Co., Ltd.K221157JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd.K222449Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)Better Care Plastic Technology Co., Ltd.K220545Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy DrugsHl Rubber Industries Sdn BhdK220491Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy DrugsHainan Asther Medical Equipment Co., Ltd.

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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