Cleared Traditional

K133070 - SURGICAL FACE MASK (Ear Loops and Tie-on)

K133070 is the FDA 510(k) clearance for SURGICAL FACE MASK (Ear Loops and Tie-on) by Bh Medical Products Co., Ltd.. It is a Class 2 General Hospital device (product code FXX) cleared through the Traditional 510(k) pathway after a 630-day FDA review.

K133070 · Bh Medical Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
630d
Days
Class 2
Risk

K133070 is an FDA 510(k) clearance for the SURGICAL FACE MASK (Ear Loops and Tie-on). Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Bh Medical Products Co., Ltd. (Dover, US). The FDA issued a Cleared decision on June 22, 2015 after a review of 630 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Bh Medical Products Co., Ltd. devices

Submission Details

510(k) Number K133070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2013
Decision Date June 22, 2015
Days to Decision 630 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
501d slower than avg
Panel avg: 129d · This submission: 630d
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 Peers - FXX Mask, Surgical

All 434
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K133070.
3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield
K180874 · 3M Healthcare · Jul 2018
Technoweb Surgical Mask
K172500 · Yts Global, Inc. · Mar 2018
Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))
K173062 · V&Q Manufacturing Corporation · Jan 2018
KC 300 SURGICAL MASK
K131879 · Kimberly-Clark Corp. · Dec 2013
KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS
K110455 · Kimberly-Clark Corp. · Apr 2011
MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD
K991559 · Medline Industries, Inc. · Aug 1999