The following data is part of a premarket notification filed by Daxwell, Llc with the FDA for Powder Free Nitrile Examination Glove.
| Device ID | K220834 |
| 510k Number | K220834 |
| Device Name: | Powder Free Nitrile Examination Glove |
| Classification | Polymer Patient Examination Glove |
| Applicant | DAXWELL, LLC 2825 Wilcrest Dr #500 Houston, TX 77042 |
| Contact | Frank Zhang |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, CN 102401 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-22 |
| Decision Date | 2022-06-29 |