Cleared Traditional

K203152 - Disposable Face Mask

K203152 is an FDA 510(k) clearance for Disposable Face Mask, manufactured by Chaozhou Cecilia Technology Co., Ltd.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 293-day FDA review.

K203152 · Chaozhou Cecilia Technology Co., Ltd. · General Hospital
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Aug 2021
Decision
293d
Days
Class 2
Risk

K203152 is an FDA 510(k) clearance for the Disposable Face Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Chaozhou Cecilia Technology Co., Ltd. (Chaozhou, CN). The FDA issued a Cleared decision on August 11, 2021 after a review of 293 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 Chaozhou Cecilia Technology Co., Ltd. devices

FDA 510(k) Submission Details - K203152

510(k) Number K203152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2020
Decision Date August 11, 2021
Days to Decision 293 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
164d slower than avg
Panel avg: 129d · This submission: 293d
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 Consultant

Imd Medical & Drug Technology Service Institutions
Salon Chen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FXX Mask, Surgical

All 444
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K203152.
Surgical mask
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Medical Face Mask
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Surgical mask
K211552 · Shandong Shengquan New Materials Co., Ltd. · Aug 2021
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K210643 · Shandong Zhushi Pharmaceutical Group Co., Ltd. · Aug 2021