The following data is part of a premarket notification filed by Zibo Goldenline Plastic Product Co., Ltd with the FDA for Goldenline Powder-free White Vinyl Patient Examination Gloves.
| Device ID | K141613 |
| 510k Number | K141613 |
| Device Name: | GOLDENLINE POWDER-FREE WHITE VINYL PATIENT EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | ZIBO GOLDENLINE PLASTIC PRODUCT CO., LTD ROOM 1606 BLDG I JIANZIANG YUAN NO. 209 BEI SI HUAN ZHONG ROAD, HAIDIAN DIS Beijing, CN 100083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan ZIBO GOLDENLINE PLASTIC PRODUCT CO., LTD ROOM 1606 BLDG I JIANZIANG 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 | 2014-06-16 |
| Decision Date | 2014-12-04 |
| Summary: | summary |