Cleared Traditional

K781682 - SURGICAL GOWNS & DRAPES

K781682 is an FDA 510(k) clearance for SURGICAL GOWNS & DRAPES, manufactured by Kimberly-Clark Corp.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K781682 · Kimberly-Clark Corp. · General Hospital
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Dec 1978
Decision
79d
Days
Class 2
Risk

K781682 is an FDA 510(k) clearance for the SURGICAL GOWNS & DRAPES. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Kimberly-Clark Corp. (Mchenry, US). The FDA issued a Cleared decision on December 20, 1978 after a review of 79 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kimberly-Clark Corp. devices

FDA 510(k) Submission Details - K781682

510(k) Number K781682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1978
Decision Date December 20, 1978
Days to Decision 79 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 129d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYA Device Classification - Class 2, Special Controls

Product Code FYA Gown, 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 - FYA Gown, Surgical

All 159
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K781682.
WHITE KNIGHT SURGICAL PACK
K800929 · G.D. Searle and Co. · May 1980
STERILIZATION PROCESS /USE GOWNS
K792622 · Procter & Gamble Mfg. Co. · Jan 1980
BOUNDARY SPECIALTY GOWN
K791062 · Procter & Gamble Mfg. Co. · Jun 1979
SURGICAL GOWN, REINFORCED
K772182 · Surgikos, Inc. · Dec 1977
APPAREL, BARRIER SCRUB
K760554 · Surgikos, Inc. · Nov 1976
BARRIER FABRIC 450 SURGICAL GOWNS
K760903 · Surgikos, Inc. · Nov 1976