The following data is part of a premarket notification filed by Hebei Astro Medical Supply Co., Ltd with the FDA for Vinyl Exam Gloves.
| Device ID | K213019 |
| 510k Number | K213019 |
| Device Name: | Vinyl Exam Gloves |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Hebei Astro Medical Supply Co., Ltd East Of Xiaoxixian, West Of Jingsan Street, South Of Weiwu Road, North Of Weiqi Road, Jinxhou Eco Jinzhou, CN 052260 |
| Contact | Ning Zheng |
| Correspondent | Diana Hong Mid-Link Consulting Co.,Ltd P.O.BOX 120-119 Shanghai, CN 200120 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-20 |
| Decision Date | 2022-01-05 |