The following data is part of a premarket notification filed by Baldur Systems Corp. with the FDA for Patient Examination Gloves (latex).
| Device ID | K892684 |
| 510k Number | K892684 |
| Device Name: | PATIENT EXAMINATION GLOVES (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | BALDUR SYSTEMS CORP. 3423 INVESTMENT BLVD., #12 Hayward, CA 94545 |
| Contact | David Hu |
| Correspondent | David Hu BALDUR SYSTEMS CORP. 3423 INVESTMENT BLVD., #12 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 | 1989-04-11 |
| Decision Date | 1989-09-11 |