The following data is part of a premarket notification filed by Wilson Glove Products Co., Ltd. with the FDA for Vinyl Powder-free Examination Gloves.
| Device ID | K946021 |
| 510k Number | K946021 |
| Device Name: | VINYL POWDER-FREE EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | WILSON GLOVE PRODUCTS CO., LTD. P O BOX 4223 Diamond Bar, CA 91765 |
| Contact | Nicholas Hung |
| Correspondent | Nicholas Hung WILSON GLOVE PRODUCTS CO., LTD. P O BOX 4223 Diamond Bar, CA 91765 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-09 |
| Decision Date | 1995-06-23 |