The following data is part of a premarket notification filed by Pt. Maja Agung Latexindo with the FDA for Powder Free Latex Examination Gloves, Black.
| Device ID | K062709 |
| 510k Number | K062709 |
| Device Name: | POWDER FREE LATEX EXAMINATION GLOVES, BLACK |
| Classification | Latex Patient Examination Glove |
| Applicant | PT. MAJA AGUNG LATEXINDO 5445 DANIEL ST. Chino, CA 91710 |
| Contact | Emmy Tjoeng |
| Correspondent | Emmy Tjoeng 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 | 2006-09-11 |
| Decision Date | 2006-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00641932180141 | K062709 | 000 |
| 00641932180134 | K062709 | 000 |
| 00641932180127 | K062709 | 000 |
| 00641932180110 | K062709 | 000 |