meddevicedb.com FDA Device Reference

B-CARE POWDERED LATEX EXAMINATION GLOVES

K052845 Traditional
Decision Date
2005-12-16
Sponsor / Applicant
B-Care Industries Co., Ltd.

Technical Specification

510(k) Submission ID K052845
Product Code OPE
Medical Specialty / Panel General Hospital
Decision Date 2005-12-16
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

B-CARE POWDERED LATEX EXAMINATION GLOVES received FDA 510(k) clearance under submission number K052845, sponsored by B-Care Industries Co., Ltd.. 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 2005-12-16.

Classification & Regulation

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