H2H Powder Free Examination Blue Glove— 510(k) K211182

Substantially Equivalent

Ntl Innovation Co., Ltd.

FDA 510(k) clearance K211182 for H2H Powder Free Examination Blue Glove, Substantially Equivalent on 2021-08-01. Applicant: Ntl Innovation Co., Ltd..

Clearance details

Applicant
Ntl Innovation Co., Ltd.
Product code
Code LZA
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hatyai District, TH
Download summary PDFView on FDA.gov ↗

Adverse events under product code LZA

product code LZA
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.