The following data is part of a premarket notification filed by Glovco Malaysia Sdn Bhd with the FDA for Patient Examination Gloves (latex).
| Device ID | K892010 |
| 510k Number | K892010 |
| Device Name: | PATIENT EXAMINATION GLOVES (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | GLOVCO MALAYSIA SDN BHD NO. 9B, JALAN SS 24/8 47301 PETALING JAYA Malaysia, MY |
| Contact | Peng Hock |
| Correspondent | Peng Hock GLOVCO MALAYSIA SDN BHD NO. 9B, JALAN SS 24/8 47301 PETALING JAYA 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 | 1989-03-30 |
| Decision Date | 1989-04-27 |