Cleared Traditional

K211832 - Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask (FDA 510(k) Clearance)

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

K211832 · Zhejiang Lanhine Medical Products, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2021
Decision
86d
Days
Class 2
Risk

K211832 is an FDA 510(k) clearance for the Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Zhejiang Lanhine Medical Products, Ltd. (Cixi, CN). The FDA issued a Cleared decision on September 8, 2021 after a review of 86 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 Zhejiang Lanhine Medical Products, Ltd. devices

Submission Details

510(k) Number K211832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2021
Decision Date September 08, 2021
Days to Decision 86 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
42d faster than avg
Panel avg: 128d · This submission: 86d
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

Shanghai Sungo Management Consulting Company Limited.
Ivy Wang

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 606
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K211832.
HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops
K251967 · O&M Halyard, Inc. · Mar 2026
Surgical Face Mask (Ear mount)
K252534 · Zhejiang Hangkang Medical Equipment Co., Ltd. · Mar 2026
Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)
K253398 · Efofex, Inc. · Feb 2026
Disposable Surgical Face Mask (3P00B, C2900)
K252830 · Beatles Medical Supplies (Xiantao) Co., Ltd. · Jan 2026
Disposable Medical Face Mask
K252650 · Makrite Industries, Inc. · Jan 2026
KP Protective Face Mask
K243342 · Kp Trading Co., Ltd. · Dec 2025