The following data is part of a premarket notification filed by Inner Mongolia Cureguard Medical Materials Co., Ltd. with the FDA for Disposable Vinyl Examination Glove.
| Device ID | K211336 |
| 510k Number | K211336 |
| Device Name: | Disposable Vinyl Examination Glove |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Inner Mongolia Cureguard Medical Materials Co., Ltd. RM 408, Building 5, Block B Of Business Science & Technology Center, Jining District Ulanqab, CN 012000 |
| Contact | Guo Hua |
| 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 | 2021-05-03 |
| Decision Date | 2021-06-16 |