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FDA 510(k)

Powder-Free Vinyl Exam Gloves, clear

K-Number: K252505 · 2025-08-28

Decision Date2025-08-28
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder-Free Vinyl Exam Gloves, clear is the device name listed in this FDA 510(k) record. The listed applicant is Basic Medical Technology, Inc.. It received FDA 510(k) clearance on 2025-08-28 under 510(k) number K252505. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Powder-Free Vinyl Exam Gloves, clear?

Powder-Free Vinyl Exam Gloves, clear is a medical device that received FDA 510(k) clearance on 2025-08-28. The listed applicant is Basic Medical Technology, Inc.. The 510(k) number is K252505.

When did Powder-Free Vinyl Exam Gloves, clear receive FDA 510(k) clearance?

Powder-Free Vinyl Exam Gloves, clear received FDA 510(k) clearance on 2025-08-28, under 510(k) number K252505.

Who is the listed applicant for Powder-Free Vinyl Exam Gloves, clear?

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

What is the FDA product code for Powder-Free Vinyl Exam Gloves, clear?

The FDA product code for Powder-Free Vinyl Exam Gloves, clear is LYZ.

Other records listing Basic Medical Technology, Inc. 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.

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Related Devices (Code: LYZ)

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.

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.