Cleared Traditional

D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply (K213970) - FDA 510(k) Clearance

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

K213970 · Danameco Medical Joint Stock Corporation · General Hospital
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Jan 2022
Decision
34d
Days
Class 2
Risk

K213970 is an FDA 510(k) clearance for the D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Danameco Medical Joint Stock Corporation (Da Nang, VN). The FDA issued a Cleared decision on January 23, 2022 after a review of 34 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Danameco Medical Joint Stock Corporation devices

Submission Details

510(k) Number K213970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2021
Decision Date January 23, 2022
Days to Decision 34 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 129d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Regulatory Technology Services, LLC
Prithul Bom

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 405
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K213970.
Surgical Face Mask
K212610 · Foshan Nanhai Plus Medical Co, Ltd. · Jan 2022
ADI Medical Surgical Face Mask
K213347 · Asia Dynamics Inc., D/B/A Adi Medical · Jan 2022
Myflon Surgical Mask Level 3
K212111 · Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi · Jan 2022
Surgical Face Mask
K203161 · Wuhan Raytex Protection Co., Ltd. · Jan 2022
Disposable Medical Mask
K212826 · Jiangsu Nanfang Medical Co., Ltd. · Jan 2022
Medical Face Mask
K210679 · Wuxi Yushou Medical Appliances Co., Ltd. · Jan 2022

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.