The following data is part of a premarket notification filed by Jiangxi Ronglai Medical Technology Co., Ltd. with the FDA for Medical Nitrile Examination Gloves.
| Device ID | K212014 |
| 510k Number | K212014 |
| Device Name: | Medical Nitrile Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Jiangxi Ronglai Medical Technology Co., Ltd. No.666 Baixu Street, Baixu Town, Jinxian County Nanchang, CN 331701 |
| Contact | Hailin Shu |
| Correspondent | Diana Hong Mid-Link Consulting Co.,Ltd. P.O.BOX 120-119 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 | 2021-06-28 |
| Decision Date | 2021-10-13 |