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FDA 510(k)

Program insite® Powder-Free, Disposable Nitrile Exam Gloves

K-Number: K252075 · 2025-10-17

ApplicantProgram Insite, LLC
Decision Date2025-10-17
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Program insite® Powder-Free, Disposable Nitrile Exam Gloves is a medical device manufactured by Program Insite, LLC. It received FDA 510(k) clearance on 2025-10-17 under approval number K252075. 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 Program insite® Powder-Free, Disposable Nitrile Exam Gloves?

Program insite® Powder-Free, Disposable Nitrile Exam Gloves is a medical device that received FDA 510(k) clearance on 2025-10-17. It is manufactured by Program Insite, LLC. The 510(k) number is K252075.

When was Program insite® Powder-Free, Disposable Nitrile Exam Gloves approved by the FDA?

Program insite® Powder-Free, Disposable Nitrile Exam Gloves received FDA 510(k) clearance on 2025-10-17, under approval number K252075.

What company makes Program insite® Powder-Free, Disposable Nitrile Exam Gloves?

Program insite® Powder-Free, Disposable Nitrile Exam Gloves is manufactured by Program Insite, LLC.

What is the FDA product code for Program insite® Powder-Free, Disposable Nitrile Exam Gloves?

The FDA product code for Program insite® Powder-Free, Disposable Nitrile Exam Gloves is LZA.

Related Devices (Code: 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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