The following data is part of a premarket notification filed by Summit Glove, Inc with the FDA for 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 (vom.
| Device ID | K220375 |
| 510k Number | K220375 |
| Device Name: | 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 (Vom |
| 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 |
|---|---|---|
| 00150020014669 | K220375 | 000 |
| 00150020014706 | K220375 | 000 |
| 00150020014683 | K220375 | 000 |
| 00150020014980 | K220375 | 000 |
| 00150020014966 | K220375 | 000 |
| 00150020014942 | K220375 | 000 |
| 00150020014904 | K220375 | 000 |
| 00150020014881 | K220375 | 000 |
| 00150020014867 | K220375 | 000 |
| 00150020014843 | K220375 | 000 |
| 00150020014829 | K220375 | 000 |
| 00150020014805 | K220375 | 000 |
| 00150018123168 | K220375 | 000 |
| 00150020014720 | K220375 | 000 |
| 00150020014744 | K220375 | 000 |
| 00150020014768 | K220375 | 000 |
| 00150020014645 | K220375 | 000 |
| 00150020014621 | K220375 | 000 |
| 00150020014607 | K220375 | 000 |
| 00150020014584 | K220375 | 000 |
| 00150020014560 | K220375 | 000 |
| 00150020014546 | K220375 | 000 |
| 00150020014515 | K220375 | 000 |
| 00150020014508 | K220375 | 000 |
| 00150020014485 | K220375 | 000 |
| 00150020014461 | K220375 | 000 |
| 00150020014447 | K220375 | 000 |
| 00150020014782 | K220375 | 000 |
| 00150018123144 | K220375 | 000 |