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FDA 510(k)

Edma Synthetic Nitrile Examination Gloves

K-Number: K211540 · 2021-08-09

ApplicantEdma Group, LLC
Decision Date2021-08-09
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Edma Synthetic Nitrile Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Edma Group, LLC. It received FDA 510(k) clearance on 2021-08-09 under 510(k) number K211540. 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 Edma Synthetic Nitrile Examination Gloves?

Edma Synthetic Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-08-09. The listed applicant is Edma Group, LLC. The 510(k) number is K211540.

When did Edma Synthetic Nitrile Examination Gloves receive FDA 510(k) clearance?

Edma Synthetic Nitrile Examination Gloves received FDA 510(k) clearance on 2021-08-09, under 510(k) number K211540.

Who is the listed applicant for Edma Synthetic Nitrile Examination Gloves?

The FDA 510(k) record lists Edma Group, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Edma Synthetic Nitrile Examination Gloves?

The FDA product code for Edma Synthetic Nitrile Examination Gloves is LZA.

Other records listing Edma Group, LLC 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.

K211547Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)

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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