The following data is part of a premarket notification filed by Pt. Maja Agung Latexindo with the FDA for Powder Free Latex Examination Gloves, Non-sterile.
| Device ID | K081488 |
| 510k Number | K081488 |
| Device Name: | POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE |
| Classification | Latex Patient Examination Glove |
| Applicant | PT. MAJA AGUNG LATEXINDO 5445 DANIELS ST. Chino, CA 91710 |
| Contact | Emmy Tjoeng |
| Correspondent | Emmy Tjoeng PT. MAJA AGUNG LATEXINDO 5445 DANIELS 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 | 2008-05-28 |
| Decision Date | 2008-08-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00641932177042 | K081488 | 000 |
| 00641932177035 | K081488 | 000 |
| 00641932177028 | K081488 | 000 |
| 00641932177011 | K081488 | 000 |