Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Premium Plastics with 9 510(k) clearances. The most recent is a 510(k) clearance dated Aug 8, 1995: PULM O2 SUCTION CATHETER TRAYS.
| Aug 8, 1995 | PULM O2 SUCTION CATHETER TRAYSK953226 · BSY | 510(k) clearances |
| Jun 21, 1995 | GENT-L-KARE TRACHEOSTOMY TRAYSK950851 · LRQ | 510(k) clearances |
| Mar 14, 1995 | GENT-L-KARE LACERATION TRAYSK950850 · FRG | 510(k) clearances |
| Dec 14, 1994 | ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY)K943740 · FMI | 510(k) clearances |
| Oct 24, 1989 | GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KITK890107 · FRO | 510(k) clearances |
| Jun 22, 1989 | GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATERK893135 · JOL | 510(k) clearances |
| Feb 28, 1985 | GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAYK850285 · KOD | 510(k) clearances |
| Apr 29, 1980 | STERILE SPONGE BOWLSK800440 · FNY | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
