The following data is part of a premarket notification filed by Tangshan Hongyun Plastic Products Co., Ltd with the FDA for Hongyun Powder-free Vinyl Patient Examination Gloves, Clear( Non-colored).
| Device ID | K142343 |
| 510k Number | K142343 |
| Device Name: | Hongyun Powder-Free Vinyl Patient Examination Gloves, Clear( Non-colored) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | TANGSHAN HONGYUN PLASTIC PRODUCTS CO., LTD SOUTH WANGGEZHUANG VILLAGE, LUANNAN COUNTY Pachigang Town, CN 063502 |
| Contact | Rj Wang |
| Correspondent | Chu Xiaoan CHU XIAON ROOM 1606 BLDG.1. BEI SI HUAN ZHONG ROAD, Beijing, CN 10008 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-21 |
| Decision Date | 2014-12-10 |
| Summary: | summary |