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FDA 510(k)

Powder-Free Nitrile Examination Glove, Non-Sterile

K-Number: K221877 · 2022-07-23

ApplicantGoodgloves Industries Sdn Bhd
Decision Date2022-07-23
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder-Free Nitrile Examination Glove, Non-Sterile is the device name listed in this FDA 510(k) record. The listed applicant is Goodgloves Industries Sdn Bhd. It received FDA 510(k) clearance on 2022-07-23 under 510(k) number K221877. 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, Non-Sterile?

Powder-Free Nitrile Examination Glove, Non-Sterile is a medical device that received FDA 510(k) clearance on 2022-07-23. The listed applicant is Goodgloves Industries Sdn Bhd. The 510(k) number is K221877.

When did Powder-Free Nitrile Examination Glove, Non-Sterile receive FDA 510(k) clearance?

Powder-Free Nitrile Examination Glove, Non-Sterile received FDA 510(k) clearance on 2022-07-23, under 510(k) number K221877.

Who is the listed applicant for Powder-Free Nitrile Examination Glove, Non-Sterile?

The FDA 510(k) record lists Goodgloves 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, Non-Sterile?

The FDA product code for Powder-Free Nitrile Examination Glove, Non-Sterile is LZA.

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

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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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