The following data is part of a premarket notification filed by Formtex Medical Sdn. Bhd. with the FDA for Latex Examination Glove Powder Free Formtex.
| Device ID | K931427 |
| 510k Number | K931427 |
| Device Name: | LATEX EXAMINATION GLOVE POWDER FREE FORMTEX |
| Classification | Latex Patient Examination Glove |
| Applicant | FORMTEX MEDICAL SDN. BHD. 7, LEBOH HISHAMUDDIN SATU KAW. 20 KAWASAN PERUSAHAAN SELAT Klang Pelabohan Klang, MY 42000 |
| Contact | Peng Hock |
| Correspondent | Peng Hock FORMTEX MEDICAL SDN. BHD. 7, LEBOH HISHAMUDDIN SATU KAW. 20 KAWASAN PERUSAHAAN SELAT Klang Pelabohan Klang, MY 42000 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-25 |
| Decision Date | 1993-10-15 |