Cleared Traditional

Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 (K210860) - FDA 510(k) Clearance

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

K210860 · Gri-Alleset, Inc. · General Hospital
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Apr 2022
Decision
380d
Days
Class 2
Risk

K210860 is an FDA 510(k) clearance for the Comfort Guard Mask, level 1, Comfort Guard Mask, level 3. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Gri-Alleset, Inc. (Flowery Branch, US). The FDA issued a Cleared decision on April 7, 2022 after a review of 380 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 Gri-Alleset, Inc. devices

Submission Details

510(k) Number K210860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2021
Decision Date April 07, 2022
Days to Decision 380 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
251d slower than avg
Panel avg: 129d · This submission: 380d
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 K210860.
Procedure Mask, Surgical Mask
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Disposable Medical Face Mask
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K214085 · Hubei Wanli Protective Products Co., Ltd. · Apr 2022
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K213450 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · Apr 2022