The following data is part of a premarket notification filed by One Touch Products Co., Ltd. with the FDA for Disposable Powder Free Vinyl Synthetic Examination Glove, White Color.
| Device ID | K033877 |
| 510k Number | K033877 |
| Device Name: | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, WHITE COLOR |
| Classification | Vinyl Patient Examination Glove |
| Applicant | ONE TOUCH PRODUCTS CO., LTD. 7668 BELPINE PLACE Rancho Cucamonga, CA 91730 |
| Contact | Elizabeth Deng |
| Correspondent | Elizabeth Deng ONE TOUCH PRODUCTS CO., LTD. 7668 BELPINE PLACE Rancho Cucamonga, CA 91730 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-15 |
| Decision Date | 2004-01-16 |