The following data is part of a premarket notification filed by Uweport Llc. with the FDA for Powder Free Nitrile Examination Glove-(test For Use With Chemotherapy Drugs).
| Device ID | K213227 |
| 510k Number | K213227 |
| Device Name: | Powder Free Nitrile Examination Glove-(Test For Use With Chemotherapy Drugs) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Uweport LLC. 3623 Latrobe Drive Suite 201 Charlotte, NC 28211 |
| Contact | Mike Wang |
| Correspondent | Elaine Duncan Paladin Medical, Inc P.O. Box 560 Stillwater, MN 55082 |
| Product Code | LZA |
| Subsequent Product Code | LZC |
| Subsequent Product Code | OPJ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-29 |
| Decision Date | 2022-01-19 |