The following data is part of a premarket notification filed by Shanghai Poseidon Plastic Products Co., Ltd. with the FDA for Multiple Private Labels, Nitrile Exam Gloves, Powder-free (white).
| Device ID | K001549 |
| 510k Number | K001549 |
| Device Name: | MULTIPLE PRIVATE LABELS, NITRILE EXAM GLOVES, POWDER-FREE (WHITE) |
| 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 | 2000-05-18 |
| Decision Date | 2000-06-12 |