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 (tested For Use With Chemotherapy Drugs).
| Device ID | K213048 |
| 510k Number | K213048 |
| Device Name: | Nitrile Patient Examination Gloves (Tested For Use With Chemotherapy Drugs) |
| 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 R Shangqiu, CN 476000 |
| Contact | Huamei Wang |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161 Lujiazui East 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 | 2021-09-22 |
| Decision Date | 2021-12-18 |