Cleared Traditional

K262007 - PRIMED AAMI Level 3 Open Back Gowns

K262007 is an FDA 510(k) clearance for PRIMED AAMI Level 3 Open Back Gowns, manufactured by Primed Medical Products, Inc.. The device is a Class 2 General Hospital device with product code QPC cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K262007 · Primed Medical Products, Inc. · General Hospital
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Sep 2026
Decision
88d
Days
Class 2
Risk

K262007 is an FDA 510(k) clearance for the PRIMED AAMI Level 3 Open Back Gowns. Classified as Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection (product code QPC), Class II - Special Controls.

Submitted by Primed Medical Products, Inc. (Edmonton, CA). The FDA issued a Cleared decision on September 11, 2026 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Primed Medical Products, Inc. devices

FDA 510(k) Submission Details - K262007

510(k) Number K262007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2026
Decision Date September 11, 2026
Days to Decision 88 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
41d faster than avg
Panel avg: 129d · This submission: 88d
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 11
Devices cleared under the same product code (QPC) and FDA review panel - the closest regulatory comparables to K262007.
VR® Personal Protective Level 4 Gown (VR Gowns)
K261115 · PolyConversions, Inc. · Aug 2026
VR® Personal Protective Level 3 Gown (VR Gowns)
K252940 · PolyConversions, Inc. · Dec 2025
AAMI Level 4 Protective
K242689 · Azac Group · Jan 2025
Medline Open-back Level 3 Protective Gown
K233526 · Medline Industries, LP · Mar 2024
PolyWear® Personal Protective Level 3 Gown
K230384 · PolyConversions, Inc. · Aug 2023
Protective Gown AAMI Level 4
K222128 · Kenpax International Limited · Aug 2023