The following data is part of a premarket notification filed by Jiangxi Zhonghong Pulin Medical Products Co., Ltd with the FDA for Vinyl Patient Examination Gloves.
| Device ID | K182117 |
| 510k Number | K182117 |
| Device Name: | Vinyl Patient Examination Gloves |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Jiangxi Zhonghong Pulin Medical Products Co., Ltd Yinsha Wan Industrial Park, High-tech Industrial Zone Of Hukou County Jiu Jiang, CN 332000 |
| Contact | Joe Zhang |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 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 | 2018-08-06 |
| Decision Date | 2018-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06974196380007 | K182117 | 000 |