The following data is part of a premarket notification filed by American Seal Co. with the FDA for Maytex Non-sterile Latex Exam Glove.
| Device ID | K892557 |
| 510k Number | K892557 |
| Device Name: | MAYTEX NON-STERILE LATEX EXAM GLOVE |
| Classification | Latex Patient Examination Glove |
| Applicant | AMERICAN SEAL CO. 25029 VIKING ST. Hayward, CA 94545 |
| Contact | Brian Hsu |
| Correspondent | Brian Hsu AMERICAN SEAL CO. 25029 VIKING ST. Hayward, CA 94545 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-10 |
| Decision Date | 1989-05-31 |