Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination Gloves— 510(k) K171743

Substantially Equivalent

Smart Glove Corporation Sdn. Bhd.

FDA 510(k) clearance K171743 for Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination Gloves, Substantially Equivalent on 2017-11-17. Applicant: Smart Glove Corporation Sdn. Bhd..

Clearance details

Applicant: Smart Glove Corporation Sdn. Bhd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2017-06-12
Decision date: 2017-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Klang, MY

Download summary PDF View on FDA.gov ↗

Adverse events under product code LZA

product code LZA

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.