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FDA 510(k)

DilaCheck Nitrile Powder Free Examination Glove, (Sterile)

K-Number: K163035 · 2017-07-07

ApplicantElm Tree Medical, Inc.
Decision Date2017-07-07
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DilaCheck Nitrile Powder Free Examination Glove, (Sterile) is the device name listed in this FDA 510(k) record. The listed applicant is Elm Tree Medical, Inc.. It received FDA 510(k) clearance on 2017-07-07 under 510(k) number K163035. 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 DilaCheck Nitrile Powder Free Examination Glove, (Sterile)?

DilaCheck Nitrile Powder Free Examination Glove, (Sterile) is a medical device that received FDA 510(k) clearance on 2017-07-07. The listed applicant is Elm Tree Medical, Inc.. The 510(k) number is K163035.

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

DilaCheck Nitrile Powder Free Examination Glove, (Sterile) received FDA 510(k) clearance on 2017-07-07, under 510(k) number K163035.

Who is the listed applicant for DilaCheck Nitrile Powder Free Examination Glove, (Sterile)?

The FDA 510(k) record lists Elm Tree Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DilaCheck Nitrile Powder Free Examination Glove, (Sterile)?

The FDA product code for DilaCheck Nitrile Powder Free Examination Glove, (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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