The following data is part of a premarket notification filed by Long First (xiamen) Co.,ltd. with the FDA for Powder Free Synthetic Vinyl Patient Examination Gloves, White Brothers.
| Device ID | K031170 |
| 510k Number | K031170 |
| Device Name: | POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE BROTHERS |
| Classification | Vinyl Patient Examination Glove |
| Applicant | LONG FIRST (XIAMEN) CO.,LTD. #23, KOOSHAN 3RD ROAD, Kaohsiung, TW |
| Contact | Stone Chen |
| Correspondent | Stone Chen LONG FIRST (XIAMEN) CO.,LTD. #23, KOOSHAN 3RD ROAD, Kaohsiung, TW |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-14 |
| Decision Date | 2003-11-13 |