The following data is part of a premarket notification filed by Hebei Astro Medical Supply Co., Ltd. with the FDA for Nitrile Exam Gloves (blue, Black).
| Device ID | K221143 |
| 510k Number | K221143 |
| Device Name: | Nitrile Exam Gloves (Blue, Black) |
| Classification | Polymer 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, Jinzhou 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 | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-20 |
| Decision Date | 2022-08-25 |