The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Finger Cots.
| Device ID | K821028 |
| 510k Number | K821028 |
| Device Name: | FINGER COTS |
| Classification | Patient Examination Glove |
| Applicant | ABCO DEALERS, INC. WI |
| Product Code | FMC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-13 |
| Decision Date | 1982-04-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FINGER COTS 73342573 not registered Dead/Abandoned |
QUALITY RUBBER PRODUCTS INCORPORATED 0000-00-00 |