The following data is part of a premarket notification filed by Ammex Corp. with the FDA for Ammex Latex Examination Gloves.
| Device ID | K891850 |
| 510k Number | K891850 |
| Device Name: | AMMEX LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | AMMEX CORP. 1720-130TH AVE. N.E. SUITE 105 Bellevue, WA 98005 |
| Contact | Jeffrey Hummel |
| Correspondent | Jeffrey Hummel AMMEX CORP. 1720-130TH AVE. N.E. SUITE 105 Bellevue, WA 98005 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-27 |
| Decision Date | 1989-04-11 |