The following data is part of a premarket notification filed by Zibo Zhouheng Plastic Products Co. Ltd with the FDA for Powder-free Yellow Vinyl Patient Examination Gloves.
| Device ID | K143347 |
| 510k Number | K143347 |
| Device Name: | Powder-Free Yellow Vinyl Patient Examination Gloves |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Zibo Zhouheng Plastic Products Co. Ltd Sanying Road Zibo, CN 255087 |
| Contact | Cherry Xu |
| Correspondent | Chu Xiaoan Zibo Zhouheng Plastic Products Co. Ltd Room 1606 Bldg. I Jianxiang Yuan No. 209 Bei Si Huan Zhong Road, Haidian Dis Beijing, CN 100083 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-21 |
| Decision Date | 2015-07-24 |
| Summary: | summary |