510(k) Report

FDA applicant

Summit Glove, Inc.

Minerva, OH5 decisions2010–20220 recalls

FDA records 5 decisions for Summit Glove, Inc. (Minerva, OH) from 2010 to 2022: 5 510(k) clearances. All are in product code LZA (Polymer Patient Examination Glove). Since 2016 its 510(k)s took a median of 63 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Summit Glove, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2022

2010: 22022: 3
2010high 3 (2022) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Summit Glove, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Summit Glove, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LZAPolymer Patient Examination Glove5decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 63 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 111 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K220373Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free, Non-sterile…Summit Glove, Inc. · 20221cites it

What has FDA decided for it lately?

  • K220371Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam…Summit Glove, Inc. · 2022
  • K220375Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips, Powder-Free, Non-sterile, Ambidextrous…Summit Glove, Inc. · 2022
  • K220373Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free, Non-sterile…Summit Glove, Inc. · 2022
  • K093517Nitritech or Multiple Private Label Non-Sterile Powder Free Nitrile Patient Examination GloveSummit Glove, Inc. · 2010
  • K093516Nitritech or Multiple Private Label Non Sterile Powdered Nitrile Examination GlovesSummit Glove, Inc. · 2010

All 5 as Summit Glove, Inc. →

Other applicant names beginning “Summit”

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

Summit Medical, Inc. 14Summit World Trade Corp. 10Summit Industries, Inc. 8Summit Doppler Systems, Inc. 7Summit Nuclear 6Summit Technology, Inc. 5Summit Medical Products, Inc. 4Summit Optics, Inc. 2Summit Spine 2Summit Medventures 2Summit Durable Medical Equipment, Inc. 1Summit TO Sea 1