The following data is part of a premarket notification filed by Shanghai Poseidon Plastic Products Co., Ltd. with the FDA for Nitrile Exam Gloves, Powder-free, Color Blue.
| Device ID | K001128 |
| 510k Number | K001128 |
| Device Name: | NITRILE EXAM GLOVES, POWDER-FREE, COLOR BLUE |
| Classification | Polymer Patient Examination Glove |
| Applicant | SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. 198 AVENUE DE LA D'EMERALD Sparks, NV 89434 -9550 |
| Contact | Janna P Tucker |
| Correspondent | Janna P Tucker SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. 198 AVENUE DE LA D'EMERALD Sparks, NV 89434 -9550 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-07 |
| Decision Date | 2000-05-23 |