The following data is part of a premarket notification filed by Pt. Maja Agung Latexindo with the FDA for Latex Powderfree Sterile Examination Gloves, Models-extra Small, Small, Medium, Large, Extra Large.
| Device ID | K013996 |
| 510k Number | K013996 |
| Device Name: | LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE |
| Classification | Latex Patient Examination Glove |
| Applicant | PT. MAJA AGUNG LATEXINDO 5445 DANIEL ST. Chino, CA 91710 |
| Contact | Emmy T Joeng |
| Correspondent | Emmy T Joeng PT. MAJA AGUNG LATEXINDO 5445 DANIEL ST. Chino, CA 91710 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-03 |
| Decision Date | 2002-02-26 |
| Summary: | summary |