FDA 510(k)

Disposable Powder Free Nitrile Examination Glove, Pink/Black Color

K-Number: K190942 · 2020-01-07

ApplicantEver Growth (Vietnam) Co. , Ltd.

Decision Date2020-01-07

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Disposable Powder Free Nitrile Examination Glove, Pink/Black Color is the device name listed in this FDA 510(k) record. The listed applicant is Ever Growth (Vietnam) Co. , Ltd.. It received FDA 510(k) clearance on 2020-01-07 under 510(k) number K190942. 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 Disposable Powder Free Nitrile Examination Glove, Pink/Black Color?

Disposable Powder Free Nitrile Examination Glove, Pink/Black Color is a medical device that received FDA 510(k) clearance on 2020-01-07. The listed applicant is Ever Growth (Vietnam) Co. , Ltd.. The 510(k) number is K190942.

When did Disposable Powder Free Nitrile Examination Glove, Pink/Black Color receive FDA 510(k) clearance?

Disposable Powder Free Nitrile Examination Glove, Pink/Black Color received FDA 510(k) clearance on 2020-01-07, under 510(k) number K190942.

Who is the listed applicant for Disposable Powder Free Nitrile Examination Glove, Pink/Black Color?

The FDA 510(k) record lists Ever Growth (Vietnam) Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Powder Free Nitrile Examination Glove, Pink/Black Color?

The FDA product code for Disposable Powder Free Nitrile Examination Glove, Pink/Black Color is LZA.

Other records listing Ever Growth (Vietnam) Co. , Ltd. 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.

K234097Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K190860Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color K190736Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs K172357Disposable Powder Free Vinyl Exam Glove, Clear/Yellow

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.