The following data is part of a premarket notification filed by Tangshan Hongyun Plastic Products Co., Ltd. with the FDA for Hongyun Powder-free Yellow Vinyl Patient Examination Gloves.
| Device ID | K141878 |
| 510k Number | K141878 |
| Device Name: | HONGYUN POWDER-FREE YELLOW VINYL PATIENT EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | TANGSHAN HONGYUN PLASTIC PRODUCTS CO., LTD. ROOM 1606 BLDG 1.JIANXIANG YUAN NO.209 BEI SI HUAN ZHONG RAOD, HIADIAN DISTRICT Beijing, CN 100083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan TANGSHAN HONGYUN PLASTIC PRODUCTS CO., LTD. ROOM 1606 BLDG 1.JIANXIANG YUAN NO.209 BEI SI HUAN ZHONG RAOD, HIADIAN DISTRICT 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 | 2014-07-11 |
| Decision Date | 2014-12-24 |
| Summary: | summary |