The following data is part of a premarket notification filed by Shanghai Poseidon Plastic Products Co., Ltd. with the FDA for Pre-powdered Non-sterile Synthetic Examination Glove.
| Device ID | K982885 |
| 510k Number | K982885 |
| Device Name: | PRE-POWDERED NON-STERILE SYNTHETIC EXAMINATION GLOVE |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. 30798 US HWY 19 N Palm Harbor, FL 34684 |
| Contact | Don Morris |
| Correspondent | Don Morris SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. 30798 US HWY 19 N Palm Harbor, FL 34684 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-17 |
| Decision Date | 1998-12-04 |