The following data is part of a premarket notification filed by Shanghai Poseidon Plastic Products Co., Ltd. with the FDA for Shanghai Poseidon Powder-free Synthetic Vinyl Examination Gloves, Yellow.
| Device ID | K992979 |
| 510k Number | K992979 |
| Device Name: | SHANGHAI POSEIDON POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. NO. 1 NEW DISTRICT ZHU HANG CHEN Jinshan Hsien, Shanghai, CN |
| Contact | Julia Wu |
| Correspondent | Julia Wu SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. NO. 1 NEW DISTRICT ZHU HANG CHEN Jinshan Hsien, Shanghai, CN |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-03 |
| Decision Date | 2000-02-09 |