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FDA 510(k)

Syntex Exam Gloves

K-Number: K253160 · 2026-01-23

Decision Date2026-01-23
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Syntex Exam Gloves 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 2026-01-23 under 510(k) number K253160. 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 Syntex Exam Gloves?

Syntex Exam Gloves is a medical device that received FDA 510(k) clearance on 2026-01-23. The listed applicant is Basic Medical Technology, Inc.. The 510(k) number is K253160.

When did Syntex Exam Gloves receive FDA 510(k) clearance?

Syntex Exam Gloves received FDA 510(k) clearance on 2026-01-23, under 510(k) number K253160.

Who is the listed applicant for Syntex Exam Gloves?

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 Syntex Exam Gloves?

The FDA product code for Syntex Exam Gloves is LZA.

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: 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.

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.