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 15, 2026, FDA's public records list Shinemound Enterprise, Inc. with 8 510(k) clearances. The most recent is a 510(k) clearance dated Sep 30, 2005: POWDERED LATEX PATIENT EXAMINATION GLOVES.
| Sep 30, 2005 | POWDERED LATEX PATIENT EXAMINATION GLOVESK051913 · LYY | 510(k) clearances |
| Jan 28, 2000 | SENSI-PRO, DISPOSABLE PRE-POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVESK994248 · LYZ | 510(k) clearances |
| Jan 20, 2000 | SENSI-PRO DISPOSABLE POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVESK994258 · LYZ | 510(k) clearances |
| Oct 27, 1999 | SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVESK993240 · LYZ | 510(k) clearances |
| Oct 27, 1999 | SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVESK993231 · LYZ | 510(k) clearances |
| Dec 22, 1997 | SYNTEXK971360 · LYZ | 510(k) clearances |
| Aug 15, 1997 | LIGHTLY POWDERED VINYL SYNTHETIC EXAMINATION GLOVESK972104 · LYZ | 510(k) clearances |
| Mar 27, 1997 | POLY-MEDK970625 · LYY | 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