FDA 510(k) Applications Submitted by Summit Glove, Inc
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K220371 |
02/09/2022 |
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) |
Summit Glove, Inc |
| K220373 |
02/09/2022 |
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 Aci |
Summit Glove, Inc |
| K220375 |
02/09/2022 |
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) |
Summit Glove, Inc |
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