Cleared Abbreviated

K160269 - Surgical Face Masks (Ear loops and Tie-on)

K160269 is an FDA 510(k) clearance for Surgical Face Masks (Ear loops and Tie-on), manufactured by San-M Package Co., Ltd.. The device is a Class 2 General Hospital device with product code FXX cleared through the Abbreviated 510(k) pathway after a 217-day FDA review.

K160269 · San-M Package Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
217d
Days
Class 2
Risk

K160269 is an FDA 510(k) clearance for the Surgical Face Masks (Ear loops and Tie-on). Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by San-M Package Co., Ltd. (Shimada-City, JP). The FDA issued a Cleared decision on September 6, 2016 after a review of 217 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 San-M Package Co., Ltd. devices

FDA 510(k) Submission Details - K160269

510(k) Number K160269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2016
Decision Date September 06, 2016
Days to Decision 217 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
88d slower than avg
Panel avg: 129d · This submission: 217d
Pathway characteristics
Standards-based clearance path.

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

Globizz Corporation
Takahiro Haruyama

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 527
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K160269.
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