The following data is part of a premarket notification filed by Inner Mongolia Boming Medical Supplies Co., Ltd. with the FDA for Disposable Nitrile Examination Glove.
| Device ID | K212467 |
| 510k Number | K212467 |
| Device Name: | Disposable Nitrile Examination Glove |
| Classification | Polymer Patient Examination Glove |
| Applicant | Inner Mongolia Boming Medical Supplies Co., Ltd. Room 326, New Industrial Park Management Committee Office Tumet Right Banner Baotou, CN 014017 |
| Contact | Guo Hua |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161,East Lujiazui 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 | 2021-08-06 |
| Decision Date | 2021-11-04 |