The following data is part of a premarket notification filed by Formosa Glove Industrial Co., Ltd. with the FDA for Nitrile Patient Examination Gloves, Powder-free, Purple.
| Device ID | K014285 |
| 510k Number | K014285 |
| Device Name: | NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE, PURPLE |
| Classification | Polymer Patient Examination Glove |
| Applicant | FORMOSA GLOVE INDUSTRIAL CO., LTD. 1016 SEWARD AVE. Westfield, NJ 07090 |
| Contact | Tiang S Chang |
| Correspondent | Tiang S Chang FORMOSA GLOVE INDUSTRIAL CO., LTD. 1016 SEWARD AVE. Westfield, NJ 07090 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-27 |
| Decision Date | 2002-02-14 |