FDA.report

510(k) K200093

Device
Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested For Use W/Chemotherapy Drug
Applicant
Anhui Lntco Medical Products Co., Ltd.
510(k) number
K200093
Product code
LZA  
Decision
Substantially Equivalent (SESE)
Decision date
2020-08-20
Date received
2020-01-16
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
Statement
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Jacken Cai
Address
# 1 Haitang Rd., Suixi District Economic Development Area Huaibei City CN 235100 235100

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Legacy Summary

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FDA Review

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