The following data is part of a premarket notification filed by Target Usa, Inc. with the FDA for Latex Examination Gloves.
| Device ID | K894079 |
| 510k Number | K894079 |
| Device Name: | LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | TARGET USA, INC. P.O. BOX 9441 PLAZA STATION Greensboro, NC 27429 |
| Contact | T Harrelson |
| Correspondent | T Harrelson TARGET USA, INC. P.O. BOX 9441 PLAZA STATION Greensboro, NC 27429 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-08 |
| Decision Date | 1989-09-13 |