The following data is part of a premarket notification filed by Pollak (intl.), Ltd. with the FDA for Embossed Disp. Poly. Gloves #5101-03.
| Device ID | K801997 |
| 510k Number | K801997 |
| Device Name: | EMBOSSED DISP. POLY. GLOVES #5101-03 |
| Classification | Patient Examination Glove |
| Applicant | POLLAK (INTL.), LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FMC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-20 |
| Decision Date | 1980-09-09 |