Data / Medical devices / United States / J&H Fulfillment LLC
J&H Fulfillment LLC: FDA-registered device maker in Elmhurst, IL, United States, 1 510(k) clearance
J&H Fulfillment LLC is registered with the FDA (registration 3014449454) in Elmhurst, IL, United States. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 4, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014449454
- Address
- 955 N WEIGEL AVENUE, Suite 100, Elmhurst, IL, United States, 60126
- Owner or operator
- J&H FULFILLMENT LLC (10059066)
- Roles
- Repackager or relabeler
- First device listed
- November 28, 2018
- Registered through
- 2026
- Brand names listed
- Face Mask, First Aid Kits, Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff, Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) Regular Cuff
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | N | Repackager or relabeler | accessdata.fda.gov |
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Repackager or relabeler | accessdata.fda.gov |
| First Aid Kit With Drug | LRR | N | 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 |
| 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 |
|---|---|---|---|---|---|---|
| August 4, 2020 | K193666 | Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff | LZA | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of First Aid Kit With Drug
- All makers of Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
- All makers of Polymer Patient Examination Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Fentanyl And Other Opioid Protection Glove
Updated August 4, 2020. 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.