The following data is part of a premarket notification filed by Canopus Medical Supply Co., Ltd. with the FDA for Disposable Power Free Vinyl Exam Glove, Pink Color.
| Device ID | K120798 |
| 510k Number | K120798 |
| Device Name: | DISPOSABLE POWER FREE VINYL EXAM GLOVE, PINK COLOR |
| Classification | Vinyl Patient Examination Glove |
| Applicant | CANOPUS MEDICAL SUPPLY CO., LTD. 18709 GREEN BAT DR., Rowland Highs, CA 91748 |
| Contact | Gloria Chang |
| Correspondent | Gloria Chang CANOPUS MEDICAL SUPPLY CO., LTD. 18709 GREEN BAT DR., Rowland Highs, CA 91748 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-15 |
| Decision Date | 2012-05-14 |