The following data is part of a premarket notification filed by Hebei Grandeast Plastic Products Co., Ltd. with the FDA for Powder-free Pvc Vinyl Exam Gloves.
| Device ID | K142703 |
| 510k Number | K142703 |
| Device Name: | Powder-free PVC Vinyl Exam Gloves |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Hebei Grandeast Plastic Products Co., Ltd. Industrial Park, Julu County Xingtai, CN 055250 |
| Contact | Wei Liu |
| Correspondent | Diana Hong MID-LINK CONSULTING CO., LTD P.O. BOX 120-119 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 | 2014-09-22 |
| Decision Date | 2015-01-15 |
| Summary: | summary |