Decision Date2025-08-28
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Powder-Free Vinyl Exam Gloves, clear is a medical device manufactured by Basic Medical Technology, Inc.. It received FDA 510(k) clearance on 2025-08-28 under approval 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. It is manufactured by Basic Medical Technology, Inc.. The 510(k) number is K252505.
When was Powder-Free Vinyl Exam Gloves, clear approved by the FDA?
Powder-Free Vinyl Exam Gloves, clear received FDA 510(k) clearance on 2025-08-28, under approval number K252505.
What company makes Powder-Free Vinyl Exam Gloves, clear?
Powder-Free Vinyl Exam Gloves, clear is manufactured by Basic Medical Technology, Inc..
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 Devices by Basic Medical Technology, Inc.
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)
K260860Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)
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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.