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FDA 510(k)

Powder Free Black Nitrile Examination Glove

K-Number: K201428 · 2021-06-24

ApplicantVietglove Corporation
Decision Date2021-06-24
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Black Nitrile Examination Glove is the device name listed in this FDA 510(k) record. The listed applicant is Vietglove Corporation. It received FDA 510(k) clearance on 2021-06-24 under 510(k) number K201428. 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 Black Nitrile Examination Glove?

Powder Free Black Nitrile Examination Glove is a medical device that received FDA 510(k) clearance on 2021-06-24. The listed applicant is Vietglove Corporation. The 510(k) number is K201428.

When did Powder Free Black Nitrile Examination Glove receive FDA 510(k) clearance?

Powder Free Black Nitrile Examination Glove received FDA 510(k) clearance on 2021-06-24, under 510(k) number K201428.

Who is the listed applicant for Powder Free Black Nitrile Examination Glove?

The FDA 510(k) record lists Vietglove Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder Free Black Nitrile Examination Glove?

The FDA product code for Powder Free Black Nitrile Examination Glove is LZA.

Other records listing Vietglove Corporation 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.

K170094POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATEDK162175Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or lessK153562Powder Free Blue Nitrile Examination Glove

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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