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FDA 510(k)

Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)

K-Number: K260860 · 2026-04-07

ApplicantBasic Medical Technology, Inc.
Decision Date2026-04-07
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) is a medical device manufactured by Basic Medical Technology, Inc.. It received FDA 510(k) clearance on 2026-04-07 under approval number K260860. 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 Synthetic Vinyl Exam Gloves (Blue, Black)?

Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) is a medical device that received FDA 510(k) clearance on 2026-04-07. It is manufactured by Basic Medical Technology, Inc.. The 510(k) number is K260860.

When was Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) approved by the FDA?

Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) received FDA 510(k) clearance on 2026-04-07, under approval number K260860.

What company makes Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)?

Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) is manufactured by Basic Medical Technology, Inc..

What is the FDA product code for Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)?

The FDA product code for Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) is LYZ.

Other Devices by Basic Medical Technology, Inc.

K252505Powder-Free Vinyl Exam Gloves, clear K251716Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate K250193Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue) K250630Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate K243792Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White) K243441Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue)

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Related Devices (Code: LYZ)

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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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