PT. Universal Gloves
MEDAN Sumatera Utara, ID
PT. UNIVERSAL GLOVES appears in FDA device records in MEDAN Sumatera Utara, ID. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for PT. Universal Gloves between 2021 and 2022. The busiest year on record is 2021, with 2. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2021 | 2 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K211360 | Disposable Nitrile Powder Free Examination Gloves (Non-sterile) | LZA | Substantially Equivalent | |
| K203074 | Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile) | LYY | Substantially Equivalent | |
| K201576 | Disposable Latex Powder Free Examination Gloves (Non-sterile) | LYY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007471500 | 3007471500 | PT. UNIVERSAL GLOVES | JL. PERTAHANAN NO.17 PATUMBAK, DELI SERDANG, MEDAN Sumatera Utara 20361 ID | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain