The following data is part of a premarket notification filed by P.t. Maja Agung Latexindo with the FDA for Surgeon's Gloves Pre-powdered, Models 6.5, 7, 7.5, 8, 8.5.
| Device ID | K992752 |
| 510k Number | K992752 |
| Device Name: | SURGEON'S GLOVES PRE-POWDERED, MODELS 6.5, 7, 7.5, 8, 8.5 |
| 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 | 1999-08-16 |
| Decision Date | 1999-11-05 |
| Summary: | summary |