Cleared Traditional

K921058 - DISPOSABLE ISOLATION GOWN

K921058 is an FDA 510(k) clearance for DISPOSABLE ISOLATION GOWN, manufactured by Nat'L Surtex Corp.. The device is a Class 2 General Hospital device with product code FYC cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K921058 · Nat'L Surtex Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
159d
Days
Class 2
Risk

K921058 is an FDA 510(k) clearance for the DISPOSABLE ISOLATION GOWN. Classified as Gown, Isolation, Surgical (product code FYC), Class II - Special Controls.

Submitted by Nat'L Surtex Corp. (Paterson, US). The FDA issued a Cleared decision on August 11, 1992 after a review of 159 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 Nat'L Surtex Corp. devices

FDA 510(k) Submission Details - K921058

510(k) Number K921058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1992
Decision Date August 11, 1992
Days to Decision 159 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
30d slower than avg
Panel avg: 129d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYC Device Classification - Class 2, Special Controls

Product Code FYC Gown, Isolation, 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 - FYC Gown, Isolation, Surgical

All 48
Devices cleared under the same product code (FYC) and FDA review panel - the closest regulatory comparables to K921058.
COVER GOWN
K952116 · American Threshold Industries, Inc. · Sep 1995
BUSE STAFF PROTECTION GOWNS AND KITS
K941845 · Busse Hospital Disposables, Inc. · May 1995
OREX ISOLATION GOWN
K945223 · Thantex Specialties, Inc. · Apr 1995
ISOLATION GOWN
K874888 · Sage Products, Inc. · Dec 1987
MAXIMUM CONTROL GOWN
K874318 · Ulti-Med Intl., Inc. · Dec 1987
DISPOSABLE ISOLATION GOWN
K851823 · American Threshold Industries, Inc. · May 1985