Data / Medical devices / United States / Ammmm, Inc.
Ammmm, Inc.: FDA-registered device maker in Rancho Palos Verdes, CA, United States, 2 510(k) clearances
Ammmm, Inc. is registered with the FDA (registration 3030187570) in Rancho Palos Verdes, CA, United States. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 20, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030187570
- Address
- 28364 S Western Ave 402, Rancho Palos Verdes, CA, United States, 90275
- Owner or operator
- AmmMm Inc. (10089629)
- Roles
- Repackager or relabeler
- First device listed
- December 26, 2023
- Registered through
- 2026
- Brand names listed
- AmmMm inc, CUSCUS, Mask ASTM Level 3 - Blue Color, Mask ASTM Level 3 - Red Color, Vaquita, Vaquita Tampons
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | 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 |
|---|---|---|---|---|---|---|
| November 20, 2022 | K221165 | Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl | LZA | Substantially Equivalent | Sri Trang Gloves (Thailand) Public Company Limited | accessdata.fda.gov |
| December 24, 2021 | K202255 | Skypro, SP02 Mask (3) | FXX | Substantially Equivalent | Skypro Medical Supplies Company | accessdata.fda.gov |
Compare with other makers
- All makers of Pad, Menstrual, Unscented
- All makers of Mask, Surgical
- All makers of Polymer Patient Examination Glove
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Glove, Specialty
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
Updated November 20, 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.