Data / Medical devices / Indonesia / PT. Sintong Unigolden Glove
PT. Sintong Unigolden Glove: FDA-registered device maker in KISARAN Sumatera Utara, Indonesia, 1 510(k) clearance
PT. Sintong Unigolden Glove is registered with the FDA (registration 3025303965) in KISARAN Sumatera Utara, Indonesia. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 26, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3025303965
- Address
- JL. Lintas Sumatera, Hessa Perlompongan Kec. Air Batu, Kab. Asahan, Sumatera Utara, KISARAN Sumatera Utara, Indonesia, 21272
- Owner or operator
- PT. SINTONG UNIGOLDEN GLOVE (10086606)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 23, 2022
- Registered through
- 2026
- Brand names listed
- NITRILE EXAMINATION GLOVES POWDER FREE TESTED FOR USE WITH CHEMOTHERAPY DRUGS & FENTANYL CITRATE (BLUE & BLACK), Nitrile Examination Glove Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black), Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs), biodegradable powder free nitrile examination glove, blue and green colors, low dermatitis potential, tested for use, biodegradable powder free nitrile examination glove, low dermatitis,potential claim, blue, green, black, white, orange,, black-white, teal-gray, white-green, white-orange, white-blue, blue-white, green-white, orange-white colors, with chemotherapy drugs, fentanyl citrate, simulated gastric acid and fentanyl citrate-simulated gastric acid solution
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Contract manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Contract manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| October 26, 2022 | K223235 | Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) | LZA | Substantially Equivalent | Pt. Sintong Unigolden Glove | accessdata.fda.gov |
Compare with other makers
- All makers of Medical Glove, Specialty
- 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 October 26, 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.