Cleared Traditional

DERMASSIST FLUID RESISTANT SURGICAL MASK (ORANGE) AND PROCEDURE MASK WITH TIE-ON AND WITH EARLOOPS (K021539) - FDA 510(k) Clearance

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

K021539 · Creative Contract (M) Sdn Bhd · General Hospital
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Mar 2003
Decision
299d
Days
Class 2
Risk

K021539 is an FDA 510(k) clearance for the DERMASSIST FLUID RESISTANT SURGICAL MASK (ORANGE) AND PROCEDURE MASK WITH TIE.... Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Creative Contract (M) Sdn Bhd (Sand Springs, US). The FDA issued a Cleared decision on March 5, 2003 after a review of 299 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 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 Creative Contract (M) Sdn Bhd devices

Submission Details

510(k) Number K021539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2002
Decision Date March 05, 2003
Days to Decision 299 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
170d slower than avg
Panel avg: 129d · This submission: 299d
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 400
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K021539.
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
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