Data / Medical devices / United States / PM Gloves, Inc.
PM Gloves, Inc.: FDA-registered device maker in Chino, CA, United States, 3 510(k) clearances
PM Gloves, Inc. is registered with the FDA (registration 2083656) in Chino, CA, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 11, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2083656
- Address
- 13808 Magnolia Ave., Chino, CA, United States, 91710
- Owner or operator
- PM GLOVES, INC. (2083656)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- August 31, 2020
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| June 11, 2018 | K171422 | Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color | LZA | Substantially Equivalent | Ever Global (Vietnam) Enterprise Corp | accessdata.fda.gov |
| March 2, 2012 | K113797 | DISPOSABLE VINYL EXAM GLOVE, POWDER FREE | LYZ | Substantially Equivalent | Full Synergy Medical Products, Inc. | accessdata.fda.gov |
| January 23, 2007 | K063524 | POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR) | LZA | Substantially Equivalent | Hl Rubber Industries Sdn Bhd | accessdata.fda.gov |
Compare with other makers
Updated June 11, 2018. 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.