The following data is part of a premarket notification filed by P.t. Maja Agung Latexindo with the FDA for Latex Surgeon Surgeon's Gloves Powder-free With Protein Content Labeling Claim (50 Micrograms Or Less).
| Device ID | K001274 |
| 510k Number | K001274 |
| Device Name: | LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
| Classification | Surgeon's Gloves |
| 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 | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-20 |
| Decision Date | 2000-06-23 |