The following data is part of a premarket notification filed by Baldur Systems Corp. with the FDA for Latex Exam Gloves (mfg. Rindumas Sdn Bhd).
| Device ID | K891727 |
| 510k Number | K891727 |
| Device Name: | LATEX EXAM GLOVES (MFG. RINDUMAS SDN BHD) |
| 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 | 1989-03-23 |
| Decision Date | 1989-05-12 |