The following data is part of a premarket notification filed by Shandong Hongxin Chemicals Co., Ltd. with the FDA for Synthetic Nitrile Examination Gloves.
| Device ID | K212488 |
| 510k Number | K212488 |
| Device Name: | Synthetic Nitrile Examination Gloves |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Shandong Hongxin Chemicals Co., Ltd. No. 10161, Xinhua Road, Zhoucun District Zibo, CN 255399 |
| Contact | Ping Wang |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161, East Lujiazui Rd., Pudong Shanghai, CN 200120 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2021-08-09 |
| Decision Date | 2021-11-26 |