Cleared Traditional

K202128 - Allmed Surgical Face Masks (Ear loops)

K202128 is an FDA 510(k) clearance for Allmed Surgical Face Masks (Ear loops), manufactured by Allmed Medical Products Co., Ltd.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 307-day FDA review.

K202128 · Allmed Medical Products Co., Ltd. · General Hospital
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Jun 2021
Decision
307d
Days
Class 2
Risk

K202128 is an FDA 510(k) clearance for the Allmed Surgical Face Masks (Ear loops). Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Allmed Medical Products Co., Ltd. (Zhijiang, CN). The FDA issued a Cleared decision on June 3, 2021 after a review of 307 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 Allmed Medical Products Co., Ltd. devices

FDA 510(k) Submission Details - K202128

510(k) Number K202128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2020
Decision Date June 03, 2021
Days to Decision 307 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
178d slower than avg
Panel avg: 129d · This submission: 307d
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 K202128.
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K210150 · Hubei Wanli Protective Products Co., Ltd. · Jun 2021
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