The following data is part of a premarket notification filed by Tianjin Aoshang Outdoor Equipment Co., Ltd. with the FDA for Synguard Nitrile Exam Glove.
| Device ID | K220442 |
| 510k Number | K220442 |
| Device Name: | Synguard Nitrile Exam Glove |
| Classification | Polymer Patient Examination Glove |
| Applicant | Tianjin Aoshang Outdoor Equipment Co., Ltd. C-1-106, No.23 Xiangtan Road, Hongqiao District Tianjin, CN 300133 |
| Contact | Xiaoning Zhang |
| 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 | 2022-02-16 |
| Decision Date | 2022-05-12 |