The following data is part of a premarket notification filed by Summit Glove, Inc with the FDA for 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).
| Device ID | K220371 |
| 510k Number | K220371 |
| Device Name: | 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) |
| 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 |
| Subsequent Product Code | LZC |
| Subsequent Product Code | QDO |
| 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 | 2022-11-02 |