The following data is part of a premarket notification filed by Hongye Plastic Products Co., Ltd. with the FDA for Powder Free Nitrile Examination Gloves (black, White, Green).
| Device ID | K122408 |
| 510k Number | K122408 |
| Device Name: | POWDER FREE NITRILE EXAMINATION GLOVES (BLACK, WHITE, GREEN) |
| Classification | Polymer Patient Examination Glove |
| Applicant | HONGYE PLASTIC PRODUCTS CO., LTD. 3973 SCHAFER AVE. Chino, CA 91710 |
| Contact | Kathy Liu |
| Correspondent | Kathy Liu HONGYE PLASTIC PRODUCTS CO., LTD. 3973 SCHAFER AVE. Chino, CA 91710 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-08 |
| Decision Date | 2013-01-17 |
| Summary: | summary |