The following data is part of a premarket notification filed by Canopus Medical Supply Co., Ltd. with the FDA for Pacer Plus Synthetic Medical Vinyl Patient Examination Glove Powder Free.
| Device ID | K963710 |
| 510k Number | K963710 |
| Device Name: | PACER PLUS SYNTHETIC MEDICAL VINYL PATIENT 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 | 1996-09-16 |
| Decision Date | 1996-10-24 |