The following data is part of a premarket notification filed by Pt. Indoraya Everlatex with the FDA for Latex Examination Gloves.
| Device ID | K912040 |
| 510k Number | K912040 |
| Device Name: | LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | PT. INDORAYA EVERLATEX JLN.A.YANI KM.22 LANDASAN ULIN BANJARBARU KALIMANTAN-SELATAN Indonesia(kode Pos 70723), ID |
| Contact | Tedjo Djtmiko |
| Correspondent | Tedjo Djtmiko PT. INDORAYA EVERLATEX JLN.A.YANI KM.22 LANDASAN ULIN BANJARBARU KALIMANTAN-SELATAN Indonesia(kode Pos 70723), ID |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-08 |
| Decision Date | 1991-12-09 |