The following data is part of a premarket notification filed by Oon Corp. Resources with the FDA for Non-sterile, Powder-free, Pink Latex Examination Gloves With And/or Without Strawberry Scent And With Protein Content.
| Device ID | K093496 |
| 510k Number | K093496 |
| Device Name: | NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVES WITH AND/OR WITHOUT STRAWBERRY SCENT AND WITH PROTEIN CONTENT |
| Classification | Latex Patient Examination Glove |
| Applicant | OON CORP. RESOURCES 198 AVE. DE LA DEMERALD Sparks, NV 89434 -9550 |
| Contact | Janna P Tucker |
| Correspondent | Janna P Tucker OON CORP. RESOURCES 198 AVE. DE LA DEMERALD Sparks, NV 89434 -9550 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-10 |
| Decision Date | 2010-02-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20304040101517 | K093496 | 000 |
| 20304040101500 | K093496 | 000 |
| 20304040101494 | K093496 | 000 |
| 20304040101487 | K093496 | 000 |
| H65811249942 | K093496 | 000 |
| H65811249912 | K093496 | 000 |