The following data is part of a premarket notification filed by Kaohsiung Brothers Products Corp. with the FDA for Brothers Powder-free Vinyl Examination Gloves.
| Device ID | K000058 |
| 510k Number | K000058 |
| Device Name: | BROTHERS POWDER-FREE VINYL EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | KAOHSIUNG BROTHERS PRODUCTS CORP. 23 KOOSHAN 3RD RD. Kaohsiung, TW 80414 |
| Contact | Stone Chen |
| Correspondent | Stone Chen KAOHSIUNG BROTHERS PRODUCTS CORP. 23 KOOSHAN 3RD RD. Kaohsiung, TW 80414 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-10 |
| Decision Date | 2000-03-10 |