Data / Medical devices / China / AOK Tooling Limited
AOK Tooling Limited: FDA-registered device maker in Shen Zhen Guangdong, China, 3 510(k) clearances
AOK Tooling Limited is registered with the FDA (registration 3006897516) in Shen Zhen Guangdong, China. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 27, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006897516
- Address
- 101 and 1Building, 2Building, 3Building, 4Building, 5Building, NO. 8 of Long Tian No. 3 Road, Long Tian Community, Long Tian Street, Ping Shan District, Shen Zhen Guangdong, China, 518122
- Owner or operator
- AOK Tooling Limited (10024686)
- Roles
- Complaint file establishment, Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer
- First device listed
- February 19, 2008
- Registered through
- 2026
- Brand names listed
- 039 Medical Surgical Face Mask (20190039), AOK 95A Medical Mask (20200049), CSC300, Hi-Ox Mask Aerosol Adapter, M. Mask (20180021-L), NOxFLOW sensor for use with NOxBOXi system, Neo-Verso Y, Plain Surgical Face Mask (20190019) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Nitric Oxide Delivery | MRN | 2 | Contract manufacturer | accessdata.fda.gov |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Connector, Airway (Extension) | BZA | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 | Contract manufacturer, Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| July 27, 2022 | K220876 | AOK 95A Medical Mask (20200049) | FXX | Substantially Equivalent | Aok Tooling Limited | accessdata.fda.gov |
| November 23, 2021 | K211956 | 039 Surgical Face Mask | FXX | Substantially Equivalent | Aok Tooling Limited | accessdata.fda.gov |
| September 4, 2020 | K201517 | Plain Surgical Mask | FXX | Substantially Equivalent | Aok Tooling Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Circuit, Breathing (W Connector, Adaptor, Y Piece)
- All makers of Apparatus, Nitric Oxide Delivery
- All makers of Respirator, Surgical
- All makers of Mask, Surgical
- All makers of Connector, Airway (Extension)
- All makers of Set, Tubing And Support, Ventilator (W Harness)
Updated July 27, 2022. 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.