Oon Corp. Resources: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Oon Corp. Resources” (first 1989, latest 2011), across 1 product code in 1 review panel. Median 510(k) review time under this name: 85 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 7 | 7 |
Review panels
- General Hospital (7)
Most recent Oon Corp. Resources 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103650 | NON-STERILE, POWDER-FREE, BLUE LATEX EXAMINATION GLOVES, WITHOUT BUBBLE GUM OR GRAPE SCENT,W/ PROTEIN CONTENT CLAIM | LYY | 2011-03-23 | 99 |
| K093496 | NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVES WITH AND/OR WITHOUT STRAWBERRY SCENT AND WITH PROTEIN CONTENT | LYY | 2010-02-03 | 85 |
| K002448 | LATEX EXAMINATION GLOVES, POWDERED, (CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM). | LYY | 2000-09-11 | 33 |
| K981917 | POWDER FREE (CHLORINATED) LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | 1998-12-07 | 189 |
| K970770 | LATEX EXAMINATION GLOVES | LYY | 1997-07-14 | 133 |
| K891511 | PATIENT EXAMINATION GLOVES (LATEX) | LYY | 1989-03-29 | 13 |
| K891424 | PATIENT EXAMINATION GLOVES (LATEX) | LYY | 1989-03-24 | 10 |
Recalls
openFDA lists no recalls under a recalling firm named Oon Corp. Resources.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Oon Corp. Resources?
FDA lists 7 510(k) clearances under the applicant name “Oon Corp. Resources” (first 1989, latest 2011), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Oon Corp. Resources?
The median time from FDA receipt to decision across 510(k)s cleared under the name Oon Corp. Resources is 85 days.
Which FDA product codes appear under Oon Corp. Resources?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 7).
Next steps
- See all 7 Oon Corp. Resources clearances with predicates and recalls
- Run predicate analysis for product code LYY, Oon Corp. Resources's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.