The following data is part of a premarket notification filed by Promedica Sdn. Bhd. with the FDA for Patient Examination Gloves (latex).
| Device ID | K891499 |
| 510k Number | K891499 |
| Device Name: | PATIENT EXAMINATION GLOVES (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | PROMEDICA SDN. BHD. 116 (BLOCK D), JALAN SEMANGAT 46100 PETALING JAYA Selangor, Malaysia, MY |
| Contact | Scheers |
| Correspondent | Scheers PROMEDICA SDN. BHD. 116 (BLOCK D), JALAN SEMANGAT 46100 PETALING JAYA Selangor, Malaysia, MY |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-16 |
| Decision Date | 1989-08-09 |