Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)— 510(k) K260860
Substantially EquivalentBasic Medical Technology, Inc.
FDA 510(k) clearance K260860 for Powder Free Synthetic Vinyl Exam Gloves (Blue, Black), Substantially Equivalent on 2026-04-07. Applicant: Basic Medical Technology, Inc.. Device class: 1.
Summary
Basic Medical Technology's Powder Free Synthetic Vinyl Exam Gloves come in blue and black, per the name, and are filed under product code LYZ (Vinyl Patient Examination Glove).
Class I, 21 CFR 880.6250. It came in as a Traditional 510(k), and General Hospital is both the classification panel and the review panel.
Basic Medical Technology filed from Ontario, California. Review took 22 calendar days (March 16 to April 7, 2026). The record flags it as a third-party review.
Clearance details
- Applicant
- Basic Medical Technology, Inc.
- Product code
- Product code LYZ
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ontario, CA, US
Recent devices under product code LYZ
view allMore clearances from Basic Medical Technology, Inc.
view all- K253160 — Syntex Exam Gloves
- K251716 — Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate
- K250193 — Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue)
- K250630 — Nitrile 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
- K243792 — Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White)
Data sourced from openFDA. This site is unofficial and independent of the FDA.