The following data is part of a premarket notification filed by Daxwell, Llc with the FDA for Powder Free Vinyl Patient Examination Gloves, Clear (non-colored).
| Device ID | K151682 |
| 510k Number | K151682 |
| Device Name: | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Daxwell, LLC 2825 Wilcrest Dr., Suite #500 Houston, TX 77042 |
| Contact | Frank Zhang |
| Correspondent | Chu Xiaoan Beijing Easylink CO.,LTD Rm. F302 Bldg., 41, Jing Cheng Ya Ju, Courtyard 6 Of Southern Dou Ge Zhuang Beijing, CN 100121 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-22 |
| Decision Date | 2015-11-17 |
| Summary: | summary |