The following data is part of a premarket notification filed by Oon Corp. Resources with the FDA for Non-sterile, Powder-free, Blue Latex Examination Gloves, Without Bubble Gum Or Grape Scent,w/ Protein Content Claim.
| Device ID | K103650 |
| 510k Number | K103650 |
| Device Name: | NON-STERILE, POWDER-FREE, BLUE LATEX EXAMINATION GLOVES, WITHOUT BUBBLE GUM OR GRAPE SCENT,W/ PROTEIN CONTENT CLAIM |
| 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 | 2010-12-14 |
| Decision Date | 2011-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20304040101418 | K103650 | 000 |
| 20304040101326 | K103650 | 000 |
| 20304040101333 | K103650 | 000 |
| 20304040101340 | K103650 | 000 |
| 20304040101357 | K103650 | 000 |
| 20304040101388 | K103650 | 000 |
| 20304040101395 | K103650 | 000 |
| 20304040101401 | K103650 | 000 |
| 20304040101425 | K103650 | 000 |
| 20304040101289 | K103650 | 000 |