The following data is part of a premarket notification filed by Tangshan Lanhai Medical Supplies Co., Ltd. with the FDA for Disposable Nitrile Examination Gloves (powder Free, Purple-blue, Blue).
| Device ID | K210898 |
| 510k Number | K210898 |
| Device Name: | Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Tangshan Lanhai Medical Supplies Co., Ltd. South Side Of Zhongda Street, East Side Of Jinxiu Road, Chengxi Industrial Zone, Luannan County Tangshan, CN 063500 |
| Contact | Li Ruidong |
| 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 | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-26 |
| Decision Date | 2021-08-26 |