The following data is part of a premarket notification filed by Zibio Yingjie Medical Products Co., Ltd with the FDA for Powder - Free Patient Examination Gloves.
| Device ID | K101565 |
| 510k Number | K101565 |
| Device Name: | POWDER - FREE PATIENT EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | ZIBIO YINGJIE MEDICAL PRODUCTS CO., LTD 12390 EAST AVE. Chino, CA 91710 |
| Contact | Frank Liu |
| Correspondent | Frank Liu ZIBIO YINGJIE MEDICAL PRODUCTS CO., LTD 12390 EAST 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 | 2010-06-04 |
| Decision Date | 2010-08-17 |
| Summary: | summary |