The following data is part of a premarket notification filed by Canopus Medical Supply Co., Ltd. with the FDA for Vinyl Examination Glove, Powder Free.
| Device ID | K941357 |
| 510k Number | K941357 |
| Device Name: | VINYL EXAMINATION GLOVE, POWDER FREE |
| Classification | Vinyl Patient Examination Glove |
| Applicant | CANOPUS MEDICAL SUPPLY CO., LTD. 9FL, NO. 50, FU-HSING N. RD. Taipei, TW |
| Contact | Ruby Lin |
| Correspondent | Ruby Lin CANOPUS MEDICAL SUPPLY CO., LTD. 9FL, NO. 50, FU-HSING N. RD. Taipei, TW |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-21 |
| Decision Date | 1994-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D76641345E2 | K941357 | 000 |
| D76641344E2 | K941357 | 000 |
| D76641343E2 | K941357 | 000 |
| D76641342E0 | K941357 | 000 |