Cleared Traditional

K210015 - Surgical Face Mask

K210015 is an FDA 510(k) clearance for Surgical Face Mask, manufactured by Sample King Manufacturing, Ltd.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K210015 · Sample King Manufacturing, Ltd. · General Hospital
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Jun 2021
Decision
157d
Days
Class 2
Risk

K210015 is an FDA 510(k) clearance for the Surgical Face Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Sample King Manufacturing, Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 10, 2021 after a review of 157 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 Sample King Manufacturing, Ltd. devices

FDA 510(k) Submission Details - K210015

510(k) Number K210015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2021
Decision Date June 10, 2021
Days to Decision 157 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
28d slower than avg
Panel avg: 129d · This submission: 157d
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 445
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K210015.
Medical Face Mask
K202714 · Chongqing Chaoke Industry Development Co., Ltd. · Jun 2021
Surgical Face Mask
K203732 · Zhuhai Gaoge Medical Technology Co., Ltd. · Jun 2021
Disposable Surgical Mask
K203756 · Lucky Textile Industrial(Wuxi) Co., Ltd. · Jun 2021
Surgical Masks, Model:FE-1
K210767 · Hunan Triplex Precision Medical Devices Co., Ltd. · Jun 2021
Disposable Surgical Mask
K202126 · Shenzhen Peninsula Medical Co., Ltd. · Jun 2021
Medical Face Mask
K211062 · Ammex-Weida (Hubei) Health and Safety Products Co., Ltd. · Jun 2021