The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Disposable Poly Gloves.
| Device ID | K841676 |
| 510k Number | K841676 |
| Device Name: | DISPOSABLE POLY GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | ABCO DEALERS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-23 |
| Decision Date | 1984-05-22 |