The following data is part of a premarket notification filed by Zibo Daiyang Plastic Company with the FDA for Daiyang Powder Free Vinyl Patient Examination Gloves, Clear (non-colored).
| Device ID | K162259 |
| 510k Number | K162259 |
| Device Name: | DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | ZIBO DAIYANG PLASTIC COMPANY NORTH OF SHIJI RD,ZHUANGYUAN INDUSTRIAL PARK, ZHANGDIAN Zibo, CN 255087 |
| Contact | Yang Yan Hong |
| Correspondent | Chu Xiaoan BEIJING EASYLINK CO.,LTD RM. F302 BLDG., 41, JING CHENG YA JU, COURTYARD 6 OF SOUTHERN DOU GE ZHUANG, Beijing, CN 100121 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-11 |
| Decision Date | 2016-12-21 |
| Summary: | summary |