The following data is part of a premarket notification filed by Formtex Medical Sdn. Bhd. with the FDA for Gamashield.
| Device ID | K900298 |
| 510k Number | K900298 |
| Device Name: | GAMASHIELD |
| Classification | Surgeon's Gloves |
| Applicant | FORMTEX MEDICAL SDN. BHD. 7, LEBOH HISHAMUDDIN SATU KAW. 20 KAWASAN PERUSAHAAN SELAT Klang Pelabohan Klang, MY 42000 |
| Contact | Low |
| Correspondent | Low FORMTEX MEDICAL SDN. BHD. 7, LEBOH HISHAMUDDIN SATU KAW. 20 KAWASAN PERUSAHAAN SELAT Klang Pelabohan Klang, MY 42000 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-23 |
| Decision Date | 1990-06-27 |