The following data is part of a premarket notification filed by Summit Glove, Inc with the FDA for 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 Gastri.
| Device ID | K220373 |
| 510k Number | K220373 |
| Device Name: | 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 Gastri |
| Classification | Polymer Patient Examination Glove |
| Applicant | Summit Glove, Inc 310 South Grant Street Minerva, OH 44657 |
| Contact | James Hull |
| Correspondent | Wava Truscott Truscott MedSci Associates, LLC 180 Burkemeade Ct. Roswell, GA 30075 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-09 |
| Decision Date | 2022-04-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00150042054100 | K220373 | 000 |
| 00150042054261 | K220373 | 000 |
| 00150042054285 | K220373 | 000 |
| 00150042054308 | K220373 | 000 |
| 00150042054322 | K220373 | 000 |
| 00150042054346 | K220373 | 000 |
| 00150042054124 | K220373 | 000 |
| 00150042054148 | K220373 | 000 |
| 00150042054162 | K220373 | 000 |
| 00150042054186 | K220373 | 000 |
| 00150042054209 | K220373 | 000 |
| 00150042054223 | K220373 | 000 |
| 00150042054018 | K220373 | 000 |
| 00150042054025 | K220373 | 000 |
| 00150042054049 | K220373 | 000 |
| 00150042054063 | K220373 | 000 |
| 00150042054087 | K220373 | 000 |
| 00150042054247 | K220373 | 000 |