The following data is part of a premarket notification filed by Hebei Titans Hongsen Medical Technology Co., Ltd. with the FDA for Vinyl Compound Examination Gloves.
| Device ID | K211229 |
| 510k Number | K211229 |
| Device Name: | Vinyl Compound Examination Gloves |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Hebei Titans Hongsen Medical Technology Co., LTD. Eastern Industrial Zone Nangong, CN 051800 |
| Contact | Feng Shuangyan |
| 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 | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-23 |
| Decision Date | 2021-07-29 |