Palm Care Blue Nitrile Examination Gloves Powder Free— 510(k) K202384

Substantially Equivalent

Hi-Care Thai Gloves Co. , Ltd.

FDA 510(k) clearance K202384 for Palm Care Blue Nitrile Examination Gloves Powder Free, Substantially Equivalent on 2020-12-02. Applicant: Hi-Care Thai Gloves Co. , Ltd.. Device class: 1.

Clearance details

Applicant
Hi-Care Thai Gloves Co. , Ltd.
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
Abbreviated
Location
Hat Yai, TH
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.