The following data is part of a premarket notification filed by Formtex Medical Sdn. Bhd. with the FDA for Non-sterile Latex Dental Procedure Gloves.
| Device ID | K903857 |
| 510k Number | K903857 |
| Device Name: | NON-STERILE LATEX DENTAL PROCEDURE GLOVES |
| 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 | C. S Low |
| Correspondent | C. S Low 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 | 1990-08-20 |
| Decision Date | 1990-10-29 |