The following data is part of a premarket notification filed by Shandong Yifan Plastic Products Co., Ltd with the FDA for Powder-free Vinyl Patient Examination Gloves, Yellow Color.
| Device ID | K122656 |
| 510k Number | K122656 |
| Device Name: | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHANDONG YIFAN PLASTIC PRODUCTS CO., LTD 12390 EAST END AVE. Chino, CA 91710 |
| Contact | Ling Zhu |
| Correspondent | Ling Zhu SHANDONG YIFAN PLASTIC PRODUCTS CO., LTD 12390 EAST END AVE. Chino, CA 91710 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-31 |
| Decision Date | 2014-05-06 |
| Summary: | summary |