The following data is part of a premarket notification filed by United Fortune International, Inc. with the FDA for Patient Examination Gloves (latex).
| Device ID | K891422 |
| 510k Number | K891422 |
| Device Name: | PATIENT EXAMINATION GLOVES (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | UNITED FORTUNE INTERNATIONAL, INC. P.O. BOX 2965 13225 BARTON CIRCLE Santa Fe Springs, CA 90670 |
| Contact | Thony Industry |
| Correspondent | Thony Industry UNITED FORTUNE INTERNATIONAL, INC. P.O. BOX 2965 13225 BARTON CIRCLE Santa Fe Springs, CA 90670 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-14 |
| Decision Date | 1989-05-12 |