Data / Medical devices / United States / Alphaprotech, Inc.
Alphaprotech, Inc.: FDA-registered device maker in Nogales, AZ, United States, 6 510(k) clearances
Alphaprotech, Inc. is registered with the FDA (registration 2022409) in Nogales, AZ, United States. It lists 8 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 21, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2022409
- Address
- 1600 W La Quinta Rd Ste 1, Nogales, AZ, United States, 85621
- Owner or operator
- ALPHAPROTECH, INC. (1721663)
- Roles
- Manufacturer, Specification developer
- First device listed
- August 31, 1995
- Registered through
- 2026
- Brand names listed
- COMBO-SHIELD, COVERALL SHIELD, Contec CritiGear Cleanroom Hood, Critical Cover 600 series, Critical Cover GenPro Hood, Critical Cover MAS 695, GenPro, MicroBreathe, ComforTech, Gown, Examination and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Specification developer | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Specification developer | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Specification developer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Manufacturer | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Specification developer | accessdata.fda.gov |
| Shoe And Shoe Cover, Conductive | BWP | 1 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| October 21, 2009 | K092824 | N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695 | MSH | Substantially Equivalent | Alpha Protech, Inc. | accessdata.fda.gov |
| 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 |
| March 21, 1988 | K875302 | MEDICAL EYE DISPOSABLE SHIELD | HOY | Substantially Equivalent | Bfd, Inc. | accessdata.fda.gov |
| January 22, 1988 | K875172 | DISPOSABLE SURGICAL FACE MASK | FXX | Substantially Equivalent | Irema USA , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Gown, Examination
- All makers of Cover, Shoe, Operating-Room
- All makers of Mask, Surgical
- All makers of Accessory, Surgical Apparel
- All makers of Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- All makers of Cap, Surgical
Updated October 21, 2009. 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.