Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL)— 510(k) K241970

Substantially Equivalent

Kanglongda Vietnam Protection Technology Company Limited

FDA 510(k) clearance K241970 for Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL), Substantially Equivalent on 2024-08-02. Applicant: Kanglongda Vietnam Protection Technology Company Limited. Device class: 1.

Clearance details

Applicant
Kanglongda Vietnam Protection Technology Company Limited
Product code
Code LZA
Device class
Class 1
Regulation
21 CFR 880.6250
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Thua Thien Hue, VN
Download summary PDFView on FDA.gov ↗

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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.