510(k) Report

FDA applicant

Star Light Ent. Corp.

Bay Village, OH1 decision1989–19890 recalls

FDA records 1 decision for Star Light Ent. Corp. (Bay Village, OH) in 1989: 1 510(k) clearance. All are in product code LYY (Latex Patient Examination Glove). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Star Light Ent. Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Star Light Ent. Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Star Light Ent. Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LYYLatex Patient Examination Glove1decision

What has FDA decided for it lately?

  • K891194Patient Examination GlovesStar Light Ent. Corp. · 1989

The one decision as Star Light Ent. Corp. →

Other applicant names beginning “Star”

FDA records each applicant name separately; these may or may not be the same firm.

Star Dental Mfg. Co. 5Star Medical Technologies, Inc. 3Star Refining Precious Metals South Africa 2Star Technologies, Inc. 2Star Dentech Korea., Corp 1Star Mountain Medical, Inc. 1Star Instrument Co. 1Star Investment and Trade Joint Stock Company 1