FDA 510(k) clearance · back to tracker

REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE

London International Group, Inc. cleared K971514 on 1997-10-29, decision: substantially equivalent

K-number

K971514

Sponsor

London International Group, Inc.

Device

REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE

Class

Class I

Decision

Substantially Equivalent

Decision date

1997-10-29

Product code

LYY

Advisory committee

General Hospital

Medical specialty

General Hospital

Regulation number

880.6250

Official FDA record

Open K971514on 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 K971514 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.