FDA 510(k) clearance · back to tracker

Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)

Basic Medical Technology, Inc. cleared K260860 on 2026-04-07, decision: substantially equivalent

K-number

K260860

Sponsor

Basic Medical Technology, Inc.

Device

Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)

Class

Class I

Decision

Substantially Equivalent

Decision date

2026-04-07

Product code

LYZ

Advisory committee

General Hospital

Medical specialty

General Hospital

Regulation number

880.6250

Official FDA record

Open K260860on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K260860 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.