Data / Medical devices / United States / Epi Printers Inc
Epi Printers Inc: FDA-registered device maker in Battle Creek, MI, United States, 6 510(k) clearances
Epi Printers Inc is registered with the FDA (registration 3008058446) in Battle Creek, MI, United States. It lists 2 device types. The FDA files 6 510(k) clearances under its listings, the newest dated July 14, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008058446
- Address
- 65 Clark Road, Battle Creek, MI, United States, 49037
- Owner or operator
- EPI Printers Inc (10060334)
- Roles
- Repackager or relabeler
- First device listed
- April 26, 2019
- Registered through
- 2026
- Brand names listed
- Kimberly-Clark Blue Nitrile Powder-Free Exam Glove, Kimberly-Clark Lavender Nitrile Powder-Free Exam Glove, Kimberly-Clark Purple Nitrile Powder-Free Exam Gloves, Kimberly-Clark Purple Nitrile-Xtra Powder-Free Exam Glove, Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove, Kimberly-Clark Sterling Nitrile Xtra Powder-Free Exam Glove
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Medical Glove, Specialty | LZC | 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 |
|---|---|---|---|---|---|---|
| July 14, 2017 | K170686 | Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| April 21, 2017 | K162294 | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| March 31, 2017 | K162186 | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM | LZC | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| March 24, 2017 | K163267 | NITRILE EXAMINATION GLOVE | LZA | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| January 5, 2017 | K162146 | Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) | LZA | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
| December 21, 2016 | K161215 | Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs | LZA | Substantially Equivalent | Brightway Holdings Sdn. Bhd. | accessdata.fda.gov |
Compare with other makers
Updated July 14, 2017. 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.