The following data is part of a premarket notification filed by P.t. Maja Agung Latexindo with the FDA for Mal Latex Examination Gloves.
| Device ID | K896604 |
| 510k Number | K896604 |
| Device Name: | MAL LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | P.T. MAJA AGUNG LATEXINDO JALAN ASIA NO: 6-B MEDAN-20214 SUMATERA-UTARA Indonesia, ID |
| Contact | Kennry Purwono |
| Correspondent | Kennry Purwono P.T. MAJA AGUNG LATEXINDO JALAN ASIA NO: 6-B MEDAN-20214 SUMATERA-UTARA Indonesia, ID |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-21 |
| Decision Date | 1990-01-02 |