The following data is part of a premarket notification filed by Zibo Goldenline Plastic Product Co., Ltd with the FDA for Powder-free Vinyl Patient Examination Gloves.
| Device ID | K083015 |
| 510k Number | K083015 |
| Device Name: | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | ZIBO GOLDENLINE PLASTIC PRODUCT CO., LTD 12390 EAST END AVE. Chino, CA 91710 |
| Contact | John Zhao |
| Correspondent | John Zhao ZIBO GOLDENLINE PLASTIC PRODUCT CO., LTD 12390 EAST END AVE. Chino, CA 91710 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-09 |
| Decision Date | 2009-03-10 |
| Summary: | summary |