# Pt. Universal Gloves

- Location (FDA's records): Medan, ID
- FDA decisions: 3 (2021–2022): 3 510(k) clearances
- Product codes: LYY (2), LZA (1)
- 510(k) review time since 2016: median 342 days, against 188 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K211360: Disposable Nitrile Powder Free Examination Gloves (Non-sterile) (Jan 15, 2022)
- K203074: Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile) (Nov 19, 2021)
- K201576: Disposable Latex Powder Free Examination Gloves (Non-sterile) (May 19, 2021)

Source page: https://510kreport.com/company/pt-universal-gloves