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FDA 510(k)

Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs

K-Number: K212148 · 2022-03-10

ApplicantAnsell Healthcare Products, LLC
Decision Date2022-03-10
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Ansell Healthcare Products, LLC. It received FDA 510(k) clearance on 2022-03-10 under 510(k) number K212148. 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 Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs?

Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2022-03-10. The listed applicant is Ansell Healthcare Products, LLC. The 510(k) number is K212148.

When did Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs receive FDA 510(k) clearance?

Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2022-03-10, under 510(k) number K212148.

Who is the listed applicant for Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs?

The FDA 510(k) record lists Ansell Healthcare Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs?

The FDA product code for Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs is LZA.

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Other records listing Ansell Healthcare Products, LLC as applicant

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.

K230079Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis PotentialK213289Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy DrugsK210401Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl CitrateK200671Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested forK190018Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy DrugsK182948Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs

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Related Devices (Code: LZA)

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.

K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.K254285Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet BlueHartalega NGC Sdn. Bhd.K252117Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid SolutionSw Technologies, Inc.K253824Powder Free Nitrile Examination Gloves Non-Sterile BlackKanglongda Vietnam Protection Technology Company LimitedK260867Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)Hartalega NGC Sdn. Bhd.K260806Nitrile Disposable Examination GlovesVista Industries,, LLC

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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