FDA 510(k)

Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl)

K-Number: K200150 · 2020-10-26

Decision Date2020-10-26

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl) is a medical device manufactured by Medline Industries, Inc.. It received FDA 510(k) clearance on 2020-10-26 under approval number K200150. 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 Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl)?

Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl) is a medical device that received FDA 510(k) clearance on 2020-10-26. It is manufactured by Medline Industries, Inc.. The 510(k) number is K200150.

When was Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl) approved by the FDA?

Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl) received FDA 510(k) clearance on 2020-10-26, under approval number K200150.

What company makes Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl)?

Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl) is manufactured by Medline Industries, Inc..

What is the FDA product code for Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl)?

The FDA product code for Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl) is LZA.

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Related Devices (Code: LZA)

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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.