Cleared Traditional

EARLOOP FACE MASK (K990719) - FDA 510(k) Clearance

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

K990719 · Shuenn Bao Shing Corp. · General Hospital
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Jul 1999
Decision
129d
Days
Class 2
Risk

K990719 is an FDA 510(k) clearance for the EARLOOP FACE MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Shuenn Bao Shing Corp. (Taipei, TW). The FDA issued a Cleared decision on July 12, 1999 after a review of 129 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Shuenn Bao Shing Corp. devices

Submission Details

510(k) Number K990719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1999
Decision Date July 12, 1999
Days to Decision 129 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 129d · This submission: 129d
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 401
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K990719.
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
MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD
K991559 · Medline Industries, Inc. · Aug 1999
DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS
K964114 · Depuy, Inc. · May 1997
MEDLINE ADMISSION KITS
K965107 · Medline Industries, Inc. · Mar 1997
3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95
K955382 · 3M Company · May 1996