# Summit Glove, Inc.

- Location (FDA's records): Minerva, OH
- FDA decisions: 5 (2010–2022): 5 510(k) clearances
- Product codes: LZA (5)
- 510(k) review time since 2016: median 63 days, against 111 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ultrawin Sdn Bhd: 2 (https://510kreport.com/company/ultrawin-sdn-bhd)

## Firms that cite its devices most
- O&M Halyard, Inc.: 1 (https://510kreport.com/company/o-m-halyard)

## Its most-cited devices
- K220373: Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit) (2022), cited by 1

## Recent decisions
- K220371: Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with the Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit) (Nov 2, 2022)
- K220375: Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Examination Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit) (Apr 13, 2022)
- K220373: Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit) (Apr 13, 2022)
- K093517: Nitritech or Multiple Private Label Non-Sterile Powder Free Nitrile Patient Examination Glove (Jun 29, 2010)
- K093516: Nitritech or Multiple Private Label Non Sterile Powdered Nitrile Examination Gloves (Jun 29, 2010)

Source page: https://510kreport.com/company/summit-glove