FDA.report

510(k) K171093

Device
STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE
Applicant
Sanrea Healthcare Products Pvt Ltd
510(k) number
K171093
Product code
LZA  
Decision
Substantially Equivalent (SESE)
Decision date
2017-07-19
Date received
2017-04-12
Regulation
880.6250
Classification name
Polymer Patient Examination Glove
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
JOSE PAUL M.
Address
Plot#P-56, Pearl Rd., Kinfra Iit Park, Kanjikode Palakkad IN 678 621 678 621

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

summary

FDA Review

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases