meddevicedb.com FDA Device Reference

LATEX EXAMINATION GLOVES

K944778 Traditional
Decision Date
1994-11-17
Sponsor / Applicant
Pt. Haloni Jane

Technical Specification

510(k) Submission ID K944778
Product Code OPE
Medical Specialty / Panel General Hospital
Decision Date 1994-11-17
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

LATEX EXAMINATION GLOVES received FDA 510(k) clearance under submission number K944778, sponsored by Pt. Haloni Jane. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1994-11-17.

Classification & Regulation

This clearance is catalogued under FDA product code OPE , within the General Hospital review panel as a device.