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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 a medical device manufactured by Elm Tree Medical, Inc.. It received FDA 510(k) clearance on 2017-07-07 under approval 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. It is manufactured by Elm Tree Medical, Inc.. The 510(k) number is K163035.

When was DilaCheck Nitrile Powder Free Examination Glove, (Sterile) approved by the FDA?

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

What company makes DilaCheck Nitrile Powder Free Examination Glove, (Sterile)?

DilaCheck Nitrile Powder Free Examination Glove, (Sterile) is manufactured by Elm Tree Medical, Inc..

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.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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