Data / Medical devices / Malaysia / Oon Corp Resources (M) Sdn Bhd
Oon Corp Resources (M) Sdn Bhd: FDA-registered device maker in SEREMBAN Negeri Sembilan, Malaysia, 4 510(k) clearances
Oon Corp Resources (M) Sdn Bhd is registered with the FDA (registration 8040936) in SEREMBAN Negeri Sembilan, Malaysia. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated March 23, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8040936
- FEI number
- 3002807808
- Address
- Lot 59, Senawang Industrial Estate, SEREMBAN Negeri Sembilan, Malaysia, 70450
- Owner or operator
- Oon Corp Resources (M) Sdn Bhd (8040936)
- Roles
- Manufacturer
- First device listed
- December 11, 2007
- Registered through
- 2026
- Brand names listed
- P-F Latex Exam Glove, P-F Latex/Blue w/bubble gum or grape scent, P-F Latex/Textured, P-F Pink Latex W/WO Strawberry scent
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 23, 2011 | K103650 | NON-STERILE, POWDER-FREE, BLUE LATEX EXAMINATION GLOVES, WITHOUT BUBBLE GUM OR GRAPE SCENT,W/ PROTEIN CONTENT CLAIM | LYY | Substantially Equivalent | Oon Corp. Resources | accessdata.fda.gov |
| February 3, 2010 | K093496 | NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVES WITH AND/OR WITHOUT STRAWBERRY SCENT AND WITH PROTEIN CONTENT | LYY | Substantially Equivalent | Oon Corp. Resources | accessdata.fda.gov |
| December 7, 1998 | K981917 | POWDER FREE (CHLORINATED) LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | Oon Corp. Resources | accessdata.fda.gov |
| July 14, 1997 | K970770 | LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | Oon Corp. Resources | accessdata.fda.gov |
Compare with other makers
Updated March 23, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.