The following data is part of a premarket notification filed by Fujian Yuanxin Safety Protection Technology Co., Ltd. with the FDA for Disposable Nitrile Examination Gloves.
| Device ID | K212485 |
| 510k Number | K212485 |
| Device Name: | Disposable Nitrile Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Fujian Yuanxin Safety Protection Technology Co., Ltd. Xiacun Medical Industry Zone, Zherong County Ningde, CN 355300 |
| Contact | Alan Wu |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room608,No.738,Shangcheng Rd.,Pudong Shanghai, CN 200120 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-09 |
| Decision Date | 2021-11-05 |