Cleared Traditional

K042654 - PROTECTION PLUS EARLOOP PROCEDURE MASK

K042654 is an FDA 510(k) clearance for PROTECTION PLUS EARLOOP PROCEDURE MASK, manufactured by Safety-Med Products, Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K042654 · Safety-Med Products, Inc. · General Hospital
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Dec 2004
Decision
80d
Days
Class 2
Risk

K042654 is an FDA 510(k) clearance for the PROTECTION PLUS EARLOOP PROCEDURE MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Safety-Med Products, Inc. (Burlington, US). The FDA issued a Cleared decision on December 17, 2004 after a review of 80 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.

FDA 510(k) Submission Details - K042654

510(k) Number K042654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2004
Decision Date December 17, 2004
Days to Decision 80 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
49d faster than avg
Panel avg: 129d · This submission: 80d
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 601
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K042654.
SURGICAL FACE MASK
K050689 · China Surgical Dressings Center Co., Ltd. · Oct 2005
NON-STERILE SURGICAL MASK
K051291 · A.R. Medicom, Inc. · Sep 2005
SURGICAL FACE MASK
K043199 · Hong YA Non-Woven Products Co., Ltd. · Feb 2005
ULTRADENT CARBON MASK - UPI #342
K041047 · Medspring Group, Incorporated · Dec 2004
VALUMAX SURGICAL MASKS (BLUE, PINK, GREEN, YELLOW, WHITE AND PEACH) WITH OR WITHOUT VISORS, TIES AND EARLOOPS
K040333 · Valumax Intl., Inc. · Jun 2004
SURGICAL FACE MASK - COLORS: WHITE, YELLOW, PINK, BLUE, AND GREEN
K022256 · Tucker & Associates · Apr 2004
K042654 · PROTECTION PLUS EARLOOP PROCEDURE MASK
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