Data / Medical devices / Indonesia / PT. Universal Gloves
PT. Universal Gloves: FDA-registered device maker in MEDAN Sumatera Utara, Indonesia, 3 510(k) clearances
PT. Universal Gloves is registered with the FDA (registration 3007471500) in MEDAN Sumatera Utara, Indonesia. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 15, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007471500
- Address
- JL. Pertahanan No.17 Patumbak, Deli Serdang, MEDAN Sumatera Utara, Indonesia, 20361
- Owner or operator
- PT. UNIVERSAL GLOVES (10061303)
- Roles
- Manufacturer
- First device listed
- June 21, 2022
- Registered through
- 2026
- Brand names listed
- UNIVERSAL GLOVES
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | 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 |
|---|---|---|---|---|---|---|
| January 15, 2022 | K211360 | Disposable Nitrile Powder Free Examination Gloves (Non-sterile) | LZA | Substantially Equivalent | Pt. Universal Gloves | accessdata.fda.gov |
| November 19, 2021 | K203074 | Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile) | LYY | Substantially Equivalent | Pt. Universal Gloves | accessdata.fda.gov |
| May 19, 2021 | K201576 | Disposable Latex Powder Free Examination Gloves (Non-sterile) | LYY | Substantially Equivalent | Pt. Universal Gloves | accessdata.fda.gov |
Compare with other makers
Updated January 15, 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.