The following data is part of a premarket notification filed by Encore Products, Inc. with the FDA for Latex Patient Examination Gloves.
| Device ID | K892573 |
| 510k Number | K892573 |
| Device Name: | LATEX PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | ENCORE PRODUCTS, INC. 400 OSER AVE. Hauppauge, NY 11788 |
| Contact | Henry Liao |
| Correspondent | Henry Liao ENCORE PRODUCTS, INC. 400 OSER AVE. Hauppauge, NY 11788 |
| 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 | 1989-07-14 |