Cleared Traditional

Surgical Face Masks, Model: EFMDS-L50Pn BLU (K230380) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 405
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K230380.
Aurelia Surgical Mask ASTM Level 1
K231005 · Supermax Healthcare Canada-Supermax Medical · Dec 2023
Biodegradable Medical surgical mask
K231155 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · Nov 2023
Surgical face mask
K232359 · Kingstar Medical (Xianning) Co., Ltd. · Oct 2023
3 Layer Surgical Mask (134252531)
K231618 · Original Mattress Factory, Inc. · Jul 2023
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