The following data is part of a premarket notification filed by Zibo Huaqi Trading Co., Ltd with the FDA for Powder Free Yellow Vinyl Patient Examination Gloves.
| Device ID | K142508 |
| 510k Number | K142508 |
| Device Name: | Powder Free Yellow Vinyl Patient Examination Gloves |
| Classification | Vinyl Patient Examination Glove |
| Applicant | ZIBO HUAQI TRADING Co., Ltd YIFAN ROAD, ZHANGDIAN DISTRICT Zibo, CN |
| Contact | Jing Li |
| Correspondent | Ray Wang Beijing Believe Tech. Service Co., Ltd. 1-202, Build 3, Beijing New World, No.5 Chaoyang Rd., Beijing, CN |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-08 |
| Decision Date | 2014-12-19 |
| Summary: | summary |