The following data is part of a premarket notification filed by Zibo Yinghao Medical Products Co., Ltd with the FDA for Powder-free Vinyl Patient Examination Gloves, Yellow Color.
| Device ID | K100486 |
| 510k Number | K100486 |
| Device Name: | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR |
| Classification | Vinyl Patient Examination Glove |
| Applicant | ZIBO YINGHAO MEDICAL PRODUCTS CO., LTD 12390 EAST END AVE Chino, CA 91710 |
| Contact | Frank Liu |
| Correspondent | Frank Liu ZIBO YINGHAO MEDICAL 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 | 2010-02-19 |
| Decision Date | 2010-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00709553682533 | K100486 | 000 |
| 00709553682434 | K100486 | 000 |
| 00709553682335 | K100486 | 000 |
| 00709553682236 | K100486 | 000 |