Cleared Traditional

K914832 - SURGICAL APPAREL

K914832 is the FDA 510(k) clearance for SURGICAL APPAREL by W.L. Gore & Associates, Inc.. It is a Class 2 General Hospital device (product code FXX) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K914832 · W.L. Gore & Associates, Inc. · General Hospital
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Feb 1992
Decision
112d
Days
Class 2
Risk

K914832 is an FDA 510(k) clearance for the SURGICAL APPAREL. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on February 14, 1992 after a review of 112 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 W.L. Gore & Associates, Inc. devices

Submission Details

510(k) Number K914832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1991
Decision Date February 14, 1992
Days to Decision 112 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 129d · This submission: 112d
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 437
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K914832.
BARRIER LASER PLUS FACE MASK
K934194 · Johnson & Johnson Medical, Inc. · Mar 1994
BARRIER EXTRA PROTECTION PLUS FACE MASK
K920108 · Johnson & Johnson Medical, Inc. · Feb 1994
CENTRAL VENOUS CATHETER, DRESSING CHANGE KIT, STER
K920846 · Trinity Laboratories, Inc. · Sep 1992
RELIABLE CONE STYLE FACE MASK
K913558 · Anago, Inc. · Nov 1991
MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKS
K913043 · Tecnol New Jersey Wound Care, Inc. · Aug 1991
FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK
K911891 · Tecnol New Jersey Wound Care, Inc. · Jul 1991