The following data is part of a premarket notification filed by P.t. Maja Agung Latexindo with the FDA for Latex Examination Gloves-pre-powdered-sterile.
| Device ID | K994255 |
| 510k Number | K994255 |
| Device Name: | LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE |
| Classification | Latex Patient Examination Glove |
| Applicant | P.T. MAJA AGUNG LATEXINDO 889 SOUTH AZUSA AVE. Industry, CA 91748 |
| Contact | Emmy Tjoeng |
| Correspondent | Emmy Tjoeng P.T. MAJA AGUNG LATEXINDO 889 SOUTH AZUSA AVE. Industry, CA 91748 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-17 |
| Decision Date | 2000-02-07 |
| Summary: | summary |