The following data is part of a premarket notification filed by Long First (xiamen) Co.,ltd. with the FDA for Brothers, Vinyl, Powder-free, Patient Examination Gloves.
| Device ID | K991085 |
| 510k Number | K991085 |
| Device Name: | BROTHERS, VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES |
| 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 | 1999-03-30 |
| Decision Date | 1999-05-05 |