Cleared Traditional

K182830 - Cardinal HealthTM Poly-Coated Open-Back Protective Gown

K182830 is an FDA 510(k) clearance for Cardinal HealthTM Poly-Coated Open-Back..., manufactured by Cardinal Health200, LLC. The device is a Class 2 General Hospital device with product code QPC cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K182830 · Cardinal Health200, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2019
Decision
203d
Days
Class 2
Risk

K182830 is an FDA 510(k) clearance for the Cardinal HealthTM Poly-Coated Open-Back Protective Gown. Classified as Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection (product code QPC), Class II - Special Controls.

Submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on April 26, 2019 after a review of 203 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Cardinal Health200, LLC devices

FDA 510(k) Submission Details - K182830

510(k) Number K182830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2018
Decision Date April 26, 2019
Days to Decision 203 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 129d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QPC Device Classification - Class 2, Special Controls

Product Code QPC Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
Definition A Non-sterile, Non-isolation Gown Intended To Be Worn By Healthcare Personnel To Provide Moderate Or High Barrier Protection In Non-sterile And Non Patient Isolation Situations. Gowns With Antimicrobial/antiviral Agents Or Claims Are Excluded.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - QPC Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection

All 10
Devices cleared under the same product code (QPC) and FDA review panel - the closest regulatory comparables to K182830.
Dukal Corporation AAMI Level 4 Open-Back Protective Gown
K212464 · Dukal Corporation · Mar 2022
Donagamex Blue Performance Protective Gown
K203821 · Dong Nai Garment Corporation (Donagamex) · Dec 2021
ProTEC-USA EZDoff Gown
K210405 · Cadillac Products, Inc. · Dec 2021
Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns
K160337 · Bam Corporation Limited · Jul 2017