FDA 510(k)

Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color)

K-Number: K220609 · 2022-05-27

Decision Date2022-05-27

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color) is the device name listed in this FDA 510(k) record. The listed applicant is Encompass Industries Sdn. Bhd.. It received FDA 510(k) clearance on 2022-05-27 under 510(k) number K220609. 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 Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color)?

Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color) is a medical device that received FDA 510(k) clearance on 2022-05-27. The listed applicant is Encompass Industries Sdn. Bhd.. The 510(k) number is K220609.

When did Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color) receive FDA 510(k) clearance?

Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color) received FDA 510(k) clearance on 2022-05-27, under 510(k) number K220609.

Who is the listed applicant for Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color)?

The FDA 510(k) record lists Encompass Industries Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color)?

The FDA product code for Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color) is LZA.

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Other records listing Encompass Industries Sdn. Bhd. as applicant

K250342Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl K183562Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs

Related Devices (Code: LZA)

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 Limited K260867Nitrile 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.