The following data is part of a premarket notification filed by Canopus Medical Supply Co., Ltd. with the FDA for Disposable Powder Free Vinyl Synthetic Exam Gloves, White Color.
| Device ID | K013753 |
| 510k Number | K013753 |
| Device Name: | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR |
| Classification | Vinyl Patient Examination Glove |
| Applicant | CANOPUS MEDICAL SUPPLY CO., LTD. 13808 MAGNOLIA AVE. Chino, CA 91710 |
| Contact | Elizabeth Deng |
| Correspondent | Elizabeth Deng CANOPUS MEDICAL SUPPLY CO., LTD. 13808 MAGNOLIA AVE. Chino, CA 91710 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-13 |
| Decision Date | 2001-12-10 |