Data / Medical devices / United States / Unite Medical, LLC
Unite Medical, LLC: FDA-registered device maker in Lithia Springs, GA, United States, 10 510(k) clearances
Unite Medical, LLC is registered with the FDA (registration 3015727296) in Lithia Springs, GA, United States. It lists 23 device types. The FDA files 10 510(k) clearances under its listings, the newest dated November 7, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015727296
- Address
- 1487 Trae Lane, Lithia Springs, GA, United States, 30122
- Owner or operator
- Unite Medical, LLC (10061044)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 20, 2019
- Registered through
- 2026
- Brand names listed
- Adjustable Offset Walking Cane with Foam Handle, Folding Walker with Front Wheels, Wide Folding Walker with Adjustable Width, Gown;Mask, Mask, Portable Pedal Exerciser with LCD Display, Hamstring and Lower Body Stretching Device, Knee Rehabilitation Glider, Portable commode chair, Toilet safety frame, RegeniCool Pro Cold Compression Therapy System, Total Joint Specialists, Respirator and more
Devices it lists
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 7, 2022 | K222898 | SafeSource Direct Blue Powder-Free Nitrile Exam Gloves | LZA | Substantially Equivalent | Safesource Direct, LLC | accessdata.fda.gov |
| May 19, 2022 | K221134 | Procedure Mask with Ear Loops and Surgical Mask with Ties | FXX | Substantially Equivalent | Safesource Direct, LLC | accessdata.fda.gov |
| November 26, 2021 | K202842 | Medical surgical mask | FXX | Substantially Equivalent | Henan Huibo Medical Co., Ltd. | accessdata.fda.gov |
| September 3, 2021 | K211762 | Altor Safety 4-Ply Surgical Mask (Model:62232) | FXX | Substantially Equivalent | Altor Safety, LLC | accessdata.fda.gov |
| July 23, 2021 | K211249 | Altor Safety 3-Ply Surgical Mask (Model:62222) | FXX | Substantially Equivalent | Altor Safety, LLC | accessdata.fda.gov |
| May 14, 2021 | K210200 | 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock | FMF | Substantially Equivalent | Set Medikal Sanayi VE Ticaret Anonim Sirketi | accessdata.fda.gov |
| December 14, 2020 | K201284 | Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use | FMF | Substantially Equivalent | Set Medikal Sanayi VE Ticaret Anonim Sirketi | accessdata.fda.gov |
| August 20, 2020 | K200093 | Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested for Use w/Chemotherapy Drug | LZA | Substantially Equivalent | Anhui Lntco Medical Products Co., Ltd. | accessdata.fda.gov |
| April 6, 2020 | K200019 | Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black) | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| August 25, 2017 | K170136 | Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Shandong Feiyang Professional Gloves Co., Ltd. | accessdata.fda.gov |
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Updated November 7, 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.