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FDA 510(k)

Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs

K-Number: K182096 · 2018-11-02

ApplicantOwens & Minor Halyard, Inc.
Decision Date2018-11-02
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs is a medical device manufactured by Owens & Minor Halyard, Inc.. It received FDA 510(k) clearance on 2018-11-02 under approval number K182096. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs?

Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2018-11-02. It is manufactured by Owens & Minor Halyard, Inc.. The 510(k) number is K182096.

When was Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs approved by the FDA?

Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2018-11-02, under approval number K182096.

What company makes Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs?

Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs is manufactured by Owens & Minor Halyard, Inc..

What is the FDA product code for Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs?

The FDA product code for Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs is LZA.

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Other Devices by Owens & Minor Halyard, Inc.

K181959HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)

Related Devices (Code: LZA)

K161215Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy DrugsBrightway Holdings Sdn. Bhd. K161932Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove PinkTerang Nusa Sdn Bhd K161944Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy DrugsShandong Baisheng Medical Products Co., Ltd. K161074Powder Free Nitrile Examination Gloves Flock-Lined, Black ColorShen Wei (Usa), Inc. K162113Powder Free Nitrile Examination Gloves (Blue)Nam Viet Glove Joint Stock Company K162095Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)Yty Industry (Manjung) 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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