Cleared Abbreviated

K080827 - HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810

K080827 is an FDA 510(k) clearance for HANDAN N95 PARTICULATE RESPIRATORS AND ..., manufactured by Handan Hengyong Protective & Clean Products Co., L. The device is a Class 2 General Hospital device with product code MSH cleared through the Abbreviated 510(k) pathway after a 10-day FDA review.

K080827 · Handan Hengyong Protective & Clean Products Co., L · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
10d
Days
Class 2
Risk

K080827 is an FDA 510(k) clearance for the HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810. Classified as Respirator, Surgical (product code MSH), Class II - Special Controls.

Submitted by Handan Hengyong Protective & Clean Products Co., L (Shijiazhuang, Hebei Province, CN). The FDA issued a Cleared decision on April 4, 2008 after a review of 10 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 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.

FDA 510(k) Submission Details - K080827

510(k) Number K080827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2008
Decision Date April 04, 2008
Days to Decision 10 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
119d faster than avg
Panel avg: 129d · This submission: 10d
Pathway characteristics
Standards-based clearance path.

MSH Device Classification - Class 2, Special Controls

Product Code MSH Respirator, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
Definition A Surgical N95 Respirator Or N95 Filtering Facepiece Respirator Is Not Exempt If It Is Intended To Prevent Specific Diseases Or Infections, Or It Is Labeled Or Otherwise Represented As Filtering Surgical Smoke Or Plumes, Filtering Specific Amounts Of Viruses Or Bacteria, Reducing The Amount Of And/or Killing Viruses, Bacteria, Or Fungi, Or Affecting Allergenicity, Or It Contains coating Technologies Unrelated To Filtration (e.g., To Reduce And Or Kill Microorganisms).  surgical N95 Respirators And N95 Filtering Facepiece Respirators Are Exempt From The Premarket Notification Procedures Subject To 21 Cfr 878.9 And The Conditions For Exemption Identified In 21 Cfr 878.4040(b)(1).
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 - MSH Respirator, Surgical

All 34
Devices cleared under the same product code (MSH) and FDA review panel - the closest regulatory comparables to K080827.
SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150
K100139 · Safelife Corp. · May 2010
N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695
K092824 · Alpha Protech, Inc. · Oct 2009
DS N95 SURGICAL MASKS AND FLAT SURGICAL
K090131 · Shanghai Dasheng Health Products · Apr 2009
N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028
K072067 · Shuenn Bao Shing Corporation · Jan 2008
AEARO COMPANY SURGICAL N95 RESPIRATORS, MODELS N9508C AND N9511C
K072359 · Aearo Company · Nov 2007
DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK
K070692 · Dukal Corporation · May 2007
K080827 · HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810
Download PDF FDA Summary Handan Hengyong Prote…