The following data is part of a premarket notification filed by Hebei Titans Hongsen Medical Technology Co., Ltd. with the FDA for Disposable Medical Rubber Examination Gloves (xs/s/m/l/xl).
| Device ID | K221374 |
| 510k Number | K221374 |
| Device Name: | Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) |
| Classification | Latex Patient Examination Glove |
| Applicant | Hebei Titans Hongsen Medical Technology Co., Ltd. Eastern Industrial Zone, Nangong City Xingtai, CN 051800 |
| Contact | Chai Wu |
| 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 | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-12 |
| Decision Date | 2022-10-26 |