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FDA 510(k)

ELAZ Nitrile Powder Free Examination Glove

K-Number: K213604 · 2022-04-03

ApplicantProtect Gloves Co., Ltd.
Decision Date2022-04-03
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ELAZ Nitrile Powder Free Examination Glove is the device name listed in this FDA 510(k) record. The listed applicant is Protect Gloves Co., Ltd.. It received FDA 510(k) clearance on 2022-04-03 under 510(k) number K213604. 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 ELAZ Nitrile Powder Free Examination Glove?

ELAZ Nitrile Powder Free Examination Glove is a medical device that received FDA 510(k) clearance on 2022-04-03. The listed applicant is Protect Gloves Co., Ltd.. The 510(k) number is K213604.

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

ELAZ Nitrile Powder Free Examination Glove received FDA 510(k) clearance on 2022-04-03, under 510(k) number K213604.

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

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

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

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

Other records listing Protect Gloves 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.

K253060Sterile Latex Powder Free Surgical Gloves

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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