The following data is part of a premarket notification filed by Jiangsu Huayuan Medical Technology Co., Ltd. with the FDA for Synthetic Vinyl Examination Gloves.
| Device ID | K211045 |
| 510k Number | K211045 |
| Device Name: | Synthetic Vinyl Examination Gloves |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Jiangsu Huayuan Medical Technology Co., Ltd. No. 36 Nanzhuang Road, High-Tech Industrial Development Zone Of Dongtai City Dongtai, CN 224299 |
| Contact | Yun Gao |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong 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 | 2021-04-08 |
| Decision Date | 2021-06-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973082350704 | K211045 | 000 |
| 06973082350698 | K211045 | 000 |
| 06973082350681 | K211045 | 000 |
| 06973082350674 | K211045 | 000 |
| 06973082350667 | K211045 | 000 |