Data / Medical devices / Indonesia / PT K-Tech Industries
PT K-Tech Industries: FDA-registered device maker in Simalungun Sumatera Utara, Indonesia, 3 510(k) clearances
PT K-Tech Industries is registered with the FDA (registration 3038187455) in Simalungun Sumatera Utara, Indonesia. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 18, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038187455
- Address
- Jalan Surfaktan Kavling D19, KEK Sei Mangkei, Desa/Kelurahan Sei Mangkei, Kec. Bosar Maligas, Kab., Simalungun Sumatera Utara, Indonesia, 21183
- Owner or operator
- PT K-Tech Industries (10093197)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- April 13, 2025
- Registered through
- 2026
- Brand names listed
- Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Nitrile Powder-Free Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| February 18, 2025 | K243792 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White) | LZA | Substantially Equivalent | Basic Medical Technology, Inc. | accessdata.fda.gov |
| January 31, 2025 | K243441 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue) | LZA | Substantially Equivalent | Basic Medical Technology, Inc. | accessdata.fda.gov |
| March 22, 2024 | K231938 | Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid | LZA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Medical Glove, Specialty
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Polymer Patient Examination Glove
Updated February 18, 2025. 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.