K250193 - Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue) (FDA 510(k) Clearance)

K250193 is an FDA 510(k) clearance for the Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, .... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Basic Medical Technology, Inc. (Ontario, US). The FDA issued a Cleared decision on July 9, 2025 after a review of 167 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Basic Medical Technology, Inc. devices