The following data is part of a premarket notification filed by Gx Corporation Sdn Bhd (plant 1) with the FDA for Multiple Name Model Multiple.
| Device ID | K093759 |
| 510k Number | K093759 |
| Device Name: | MULTIPLE NAME MODEL MULTIPLE |
| Classification | Polymer Patient Examination Glove |
| Applicant | GX CORPORATION SDN BHD (PLANT 1) LOT 6487-A, BATU 5 3/4 SEMENTA JALAN KAPAR Klang, Selangor, MY |
| Contact | Cho Sow Fong |
| Correspondent | Cho Sow Fong GX CORPORATION SDN BHD (PLANT 1) LOT 6487-A, BATU 5 3/4 SEMENTA JALAN KAPAR Klang, Selangor, MY |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-07 |
| Decision Date | 2010-02-19 |