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 |