The following data is part of a premarket notification filed by Youngshengplastic Co., Ltd with the FDA for Powder-free Vinyl Patient Examination Gloves.
| Device ID | K103198 |
| 510k Number | K103198 |
| Device Name: | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | YOUNGSHENGPLASTIC CO., LTD NEW INDUSTRIAL PARK Xinciangcity, CN 453003 |
| Contact | Wu Wei |
| Correspondent | Wu Wei YOUNGSHENGPLASTIC CO., LTD NEW INDUSTRIAL PARK Xinciangcity, CN 453003 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-29 |
| Decision Date | 2010-12-20 |
| Summary: | summary |