GUARDIAN STERILIZATION WRAP— 510(k) K803294

Name: FDA 510(k) clearance K803294
Creator: U.S. Food and Drug Administration
Published: 1981-02-02

Substantially Equivalent

Kimberly-Clark Corp.

FDA 510(k) clearance K803294 for GUARDIAN STERILIZATION WRAP, Substantially Equivalent on 1981-02-02. Applicant: Kimberly-Clark Corp.. Device class: 2.

Clearance details

Applicant: Kimberly-Clark Corp.
Product code: Code FRG
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 1980-12-30
Decision date: 1981-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K131879 — KC 300 SURGICAL MASK2013-12-20
K131841 — KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE2013-11-07
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Adverse events under product code FRG

product code FRG

Other: 3
Total: 3

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.