The following data is part of a premarket notification filed by Huayuan Medical Technology(shangqiu) Co., Ltd. with the FDA for Nitrile Patient Examination Gloves.
| Device ID | K211028 |
| 510k Number | K211028 |
| Device Name: | Nitrile Patient Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Huayuan Medical Technology(Shangqiu) Co., Ltd. In The North Yard Of West 1000m Road At The Intersection Of Zhuangzhou Avenue And Pingyuan Road, Liangyuan District Shangqiu, CN 476000 |
| Contact | Huamei Wang |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng 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 | 2021-04-06 |
| Decision Date | 2021-06-04 |