The following data is part of a premarket notification filed by Anhui Xinyisheng Medical Technology Co.,ltd with the FDA for Disposable Medical Nitrile Examination Gloves (model:xys-001).
| Device ID | K213371 |
| 510k Number | K213371 |
| Device Name: | Disposable Medical Nitrile Examination Gloves (Model:XYS-001) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Anhui Xinyisheng Medical Technology Co.,Ltd No.999 North Of The Intersection Of Tonghe Road And G343 Road Si County Suzhou, CN 234000 |
| Contact | Shyla Tang |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-10-12 |
| Decision Date | 2021-12-09 |