Cleared Traditional

K940228 - BOUFFANT CAP

K940228 is an FDA 510(k) clearance for BOUFFANT CAP, manufactured by Derekduck Industries Corp.. The device is a Class 1 General Hospital device with product code LYU cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K940228 · Derekduck Industries Corp. · General Hospital
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Sep 1994
Decision
255d
Days
Class 1
Risk

K940228 is an FDA 510(k) clearance for the BOUFFANT CAP. Classified as Accessory, Surgical Apparel (product code LYU), Class I - General Controls.

Submitted by Derekduck Industries Corp. (Taipei,Taiwan, CN). The FDA issued a Cleared decision on September 26, 1994 after a review of 255 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 Derekduck Industries Corp. devices

FDA 510(k) Submission Details - K940228

510(k) Number K940228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1994
Decision Date September 26, 1994
Days to Decision 255 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
126d slower than avg
Panel avg: 129d · This submission: 255d
Pathway characteristics
Predicate-based equivalence.

LYU Device Classification - Class 1, General Controls

Product Code LYU Accessory, Surgical Apparel
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LYU Accessory, Surgical Apparel

All 16
Devices cleared under the same product code (LYU) and FDA review panel - the closest regulatory comparables to K940228.
SLOAN STA-DRI PANT PROTECTOR
K945302 · Sloan Corp. · Mar 1996
ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS
K942200 · Thantex Specialties, Inc. · Aug 1995
MAKAR FULL AND HALF FACE SHIELD
K942828 · Instrument Makar, Inc. · Feb 1995
FACE-IT SHIELD
K942022 · Onyx Medical Corp. · Jul 1994
TECNOL SPLASHGUARD
K934842 · Tecnol Medical Products, Inc. · Mar 1994
PROCEL(TM) DERMALINER GLOVE
K931094 · W.L. Gore & Associates, Inc. · Feb 1994