Cleared Abbreviated

K211487 - MAF Guard (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K211487 · Maf Clothing Pvt Ltd Unit-3 · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2021
Decision
209d
Days
Class 2
Risk

K211487 is an FDA 510(k) clearance for the MAF Guard. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Maf Clothing Pvt Ltd Unit-3 (Karnataka, IN). The FDA issued a Cleared decision on December 8, 2021 after a review of 209 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Maf Clothing Pvt Ltd Unit-3 devices

Submission Details

510(k) Number K211487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2021
Decision Date December 08, 2021
Days to Decision 209 days
Submission Type Abbreviated
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
81d slower than avg
Panel avg: 128d · This submission: 209d
Pathway characteristics
Standards-based clearance path.

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

Benjamin L. England and Associates, LLC
Thomas C. Knott

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 K211487.
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