The following data is part of a premarket notification filed by Glovoco (m) Sdn Bhd with the FDA for Examination Gloves Powder Free.
| Device ID | K923089 |
| 510k Number | K923089 |
| Device Name: | EXAMINATION GLOVES POWDER FREE |
| Classification | Latex Patient Examination Glove |
| Applicant | GLOVOCO (M) SDN BHD LOT 2, JALAN PERSIARAN HISHAMUDDIN, KAWASAN 20 SELAT Klang Satu Malaysia, MY |
| Contact | Peng Hock |
| Correspondent | Peng Hock GLOVOCO (M) SDN BHD LOT 2, JALAN PERSIARAN HISHAMUDDIN, KAWASAN 20 SELAT Klang Satu 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 | 1992-06-25 |
| Decision Date | 1993-06-22 |