Disposable Nitrile Powder Free Examination Gloves (Non-sterile)— 510(k) K211360

Substantially Equivalent

Pt. Universal Gloves

FDA 510(k) clearance K211360 for Disposable Nitrile Powder Free Examination Gloves (Non-sterile), Substantially Equivalent on 2022-01-15. Applicant: Pt. Universal Gloves.

Clearance details

Applicant: Pt. Universal Gloves
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2021-05-03
Decision date: 2022-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medan, ID

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.