Cleared Traditional

K230380 - Surgical Face Masks

K230380 is an FDA 510(k) clearance for Surgical Face Masks, manufactured by Iris USA. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K230380 · Iris USA · General Hospital
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Aug 2023
Decision
171d
Days
Class 2
Risk

K230380 is an FDA 510(k) clearance for the Surgical Face Masks, Model: EFMDS-L50Pn BLU. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Iris USA (Pleasant Prairie, US). The FDA issued a Cleared decision on August 3, 2023 after a review of 171 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 Iris USA devices

FDA 510(k) Submission Details - K230380

510(k) Number K230380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2023
Decision Date August 03, 2023
Days to Decision 171 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 129d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FXX Device Classification - Class 2, Special Controls

Product Code FXX Mask, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
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 - FXX Mask, Surgical

All 444
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K230380.
Aurelia Surgical Mask ASTM Level 1
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K231155 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · Nov 2023
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3 Layer Surgical Mask (134252531)
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Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)
K230395 · Durio Ppe Sdn Bhd · Jul 2023
Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 )
K230569 · Cardinalhealth · Jul 2023