Cleared Traditional

K201991 - Medical surgical mask

K201991 is the FDA 510(k) clearance for Medical surgical mask by Shenzhen Everwin Precision Technology Co., Ltd.. It is a Class 2 General Hospital device (product code FXX) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K201991 · Shenzhen Everwin Precision Technology Co., Ltd. · General Hospital
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Nov 2020
Decision
129d
Days
Class 2
Risk

K201991 is an FDA 510(k) clearance for the Medical surgical mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Shenzhen Everwin Precision Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 23, 2020 after a review of 129 days - within the typical 510(k) review window.

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 Shenzhen Everwin Precision Technology Co., Ltd. devices

Submission Details

510(k) Number K201991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2020
Decision Date November 23, 2020
Days to Decision 129 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
At panel average
Panel avg: 129d · This submission: 129d
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 Consultant

Guangzhou Osmunda Medical Device Technical Services Co., Ltd.
Olivia Meng

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 436
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