Data / Medical devices / United States / TNG Worldwide Inc
TNG Worldwide Inc: FDA-registered device maker in New Hudson, MI, United States, 3 510(k) clearances
TNG Worldwide Inc is registered with the FDA (registration 3009503464) in New Hudson, MI, United States. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 25, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009503464
- Address
- 29683 W K Smith Dr, New Hudson, MI, United States, 48165
- Owner or operator
- TNG Worldwide Inc (10045514)
- Roles
- Specification developer
- First device listed
- October 24, 2023
- Registered through
- 2026
- Brand names listed
- FOR PRO, For Pro Alcohol prep pad IW 200Cnt., For Pro Tongue depressor, For Pro Zyra, For pro
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Depressor, Tongue, Non-Surgical | FMA | 1 | Specification developer | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Specification developer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Specification developer | accessdata.fda.gov |
| Pad, Alcohol, Device Disinfectant | LKB | U | Specification developer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | 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 |
|---|---|---|---|---|---|---|
| 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 |
| October 21, 2015 | K151836 | NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| March 20, 2013 | K121655 | BD ALCOHOL SWAB | LKB | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Depressor, Tongue, Non-Surgical
- All makers of Gauze / Sponge,Nonresorbable For External Use
- All makers of Pad, Alcohol, Device Disinfectant
Updated August 25, 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.