FDA 510(k) clearance · back to tracker

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Basic Medical Technology, Inc. cleared K252505 on 2025-08-28, decision: substantially equivalent

K-number

K252505

Sponsor

Basic Medical Technology, Inc.

Device

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Class

Class I

Decision

Substantially Equivalent

Decision date

2025-08-28

Product code

LYZ

Advisory committee

General Hospital

Medical specialty

General Hospital

Regulation number

880.6250

Official FDA record

Open K252505on 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 K252505 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.