Cleared Traditional

K861600 - SPUNGUARD PLUS SURGICAL GOWN

K861600 is an FDA 510(k) clearance for SPUNGUARD PLUS SURGICAL GOWN, 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 13-day FDA review.

K861600 · Kimberly-Clark Corp. · General Hospital
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May 1986
Decision
13d
Days
Class 2
Risk

K861600 is an FDA 510(k) clearance for the SPUNGUARD PLUS SURGICAL GOWN. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Kimberly-Clark Corp. (Roswell, US). The FDA issued a Cleared decision on May 12, 1986 after a review of 13 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 - K861600

510(k) Number K861600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1986
Decision Date May 12, 1986
Days to Decision 13 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
116d faster than avg
Panel avg: 129d · This submission: 13d
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 K861600.
KIMBERLY-CLARK FULL LENGTH HEAVY DUTY APRON
K880383 · Kimberly-Clark Corp. · Jun 1988
KIMBERLY-CLARK PROTECTIVE SLEEVE
K880386 · Kimberly-Clark Corp. · Jun 1988
THEATRE GOWNS
K872758 · Smith & Nephew, Inc. · Jul 1987
BARRIER SURGICAL GOWN
K852870 · Surgikos, Inc. · Jul 1985
TURQUOISE
K851559 · Roseburg SA · Apr 1985
BOUNDARY SINGLE-USE OR GOWN
K842958 · Procter & Gamble Mfg. Co. · Aug 1984