The following data is part of a premarket notification filed by Zibo Changda Plastic Products Company, Limited with the FDA for Powder-free White Vinyl Patient Examination Gloves.
| Device ID | K143346 |
| 510k Number | K143346 |
| Device Name: | Powder-Free White Vinyl Patient Examination Gloves |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Zibo Changda Plastic Products Company, Limited Yumin Road Zibo, CN 255000 |
| Contact | Coco Kou |
| Correspondent | Chu Xiaoan Zibo Changda Plastic Products Company, Limited Room 1606 Bldg .1. 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 | 2015-07-22 |
| Summary: | summary |