Cleared Traditional

K210405 - ProTEC-USA EZDoff Gown

K210405 is an FDA 510(k) clearance for ProTEC-USA EZDoff Gown, manufactured by Cadillac Products, Inc.. The device is a Class 2 General Hospital device with product code QPC cleared through the Traditional 510(k) pathway after a 308-day FDA review.

K210405 · Cadillac Products, Inc. · General Hospital
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Dec 2021
Decision
308d
Days
Class 2
Risk

K210405 is an FDA 510(k) clearance for the ProTEC-USA EZDoff 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 Cadillac Products, Inc. (Troy, US). The FDA issued a Cleared decision on December 15, 2021 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Cadillac Products, Inc. devices

FDA 510(k) Submission Details - K210405

510(k) Number K210405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2021
Decision Date December 15, 2021
Days to Decision 308 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
179d slower than avg
Panel avg: 129d · This submission: 308d
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 Consultant

Morgan, Lewis, & Bockius, Llp
Dennis Gucciardo

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

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