The following data is part of a premarket notification filed by Leping Shengde Medical Technology Company Limited with the FDA for Disposable Nitrile Examination Gloves (powder Free, Blue).
| Device ID | K211581 |
| 510k Number | K211581 |
| Device Name: | Disposable Nitrile Examination Gloves (Powder Free, Blue) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Leping Shengde Medical Technology Company Limited No.17, Yubao Village, Lingang Village Committee, Lingang Town, Leping City Jingdezhen, CN 333300 |
| Contact | Sheng Jianchao |
| 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 | 2021-05-21 |
| Decision Date | 2021-10-28 |