Cleared Traditional

SURGICAL APPAREL (K914832) - FDA 510(k) Clearance

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

K914832 · W.L. Gore & Associates, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
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 400
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K914832.
MEDLINE ADMISSION KITS
K965107 · Medline Industries, Inc. · Mar 1997
3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95
K955382 · 3M Company · May 1996
3M SURGICAL MASK WITH FACE SHEILD
K940707 · 3M Company · May 1994
TRIPLE LAYER FLUID-RESISTANT MOLDED FACE MASK
K910110 · 3M Company · Mar 1991
3M BRAND EAR LOOP FACE MASK, 2000F
K910182 · 3M Company · Mar 1991
ASEPTEX 1812 SUB-MICRON MOLDED SURGICAL MASK
K890771 · 3M Company · Mar 1989