Data / Medical devices / Mexico / Manufacturas Ke
Manufacturas Ke: FDA-registered device maker in Nogales Sonora, Mexico, 5 510(k) clearances
Manufacturas Ke is registered with the FDA (registration 3006582165) in Nogales Sonora, Mexico. It lists 7 device types. The FDA files 5 510(k) clearances under its listings, the newest dated February 14, 1989. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006582165
- Address
- Alejandro Perez Rocha 82, Nogales Sonora, Mexico, 84094
- Owner or operator
- Manufacturas KE (10032451)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler
- First device listed
- May 13, 2010
- Registered through
- 2026
- Brand names listed
- Add-A-Shield, Aprons, AquaTrak, Beard Covers, Bouffant Caps, Combo-Shield, Coverall Shields, Coveralls and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Shoe And Shoe Cover, Conductive | BWP | 1 | Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| February 14, 1989 | K890128 | FACELOCK FILTER MASK | FXX | Substantially Equivalent | Alpha Protech, Inc. | accessdata.fda.gov |
| June 15, 1988 | K882028 | COVERALL SHIELD | FXX | Substantially Equivalent | Bfd, Inc. | accessdata.fda.gov |
| June 15, 1988 | K882027 | COMBO-SHIELD | FXX | Substantially Equivalent | Bfd, Inc. | accessdata.fda.gov |
| June 15, 1988 | K882026 | ADD-A-SHIELD | FXX | Substantially Equivalent | Bfd, Inc. | accessdata.fda.gov |
| March 21, 1988 | K875302 | MEDICAL EYE DISPOSABLE SHIELD | HOY | Substantially Equivalent | Bfd, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Mask, Surgical
- All makers of Shoe And Shoe Cover, Conductive
- All makers of Accessory, Surgical Apparel
- All makers of Gown, Examination
- All makers of Cover, Shoe, Operating-Room
- All makers of Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Updated February 14, 1989. 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.