The following data is part of a premarket notification filed by Shanghai Poseidon Plastic Products Co., Ltd. with the FDA for Powder Free Vinyl Examination Glove.
| Device ID | K964545 |
| 510k Number | K964545 |
| Device Name: | POWDER FREE VINYL EXAMINATION GLOVE |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. 1202 SOUTH ROUTE 31 Mc Henry, IL 60050 |
| Contact | Anthony L Giaccio |
| Correspondent | Anthony L Giaccio SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. 1202 SOUTH ROUTE 31 Mc Henry, IL 60050 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-13 |
| Decision Date | 1996-12-30 |