Cleared Traditional

K833877 - SINGLE-USE SURGICAL DRAPES

K833877 is an FDA 510(k) clearance for SINGLE-USE SURGICAL DRAPES, manufactured by Procter & Gamble Mfg. Co.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K833877 · Procter & Gamble Mfg. Co. · General Hospital
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Jan 1984
Decision
78d
Days
Class 2
Risk

K833877 is an FDA 510(k) clearance for the SINGLE-USE SURGICAL DRAPES. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Procter & Gamble Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on January 25, 1984 after a review of 78 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - 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 Procter & Gamble Mfg. Co. devices

FDA 510(k) Submission Details - K833877

510(k) Number K833877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1983
Decision Date January 25, 1984
Days to Decision 78 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
51d faster than avg
Panel avg: 129d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KKX Device Classification - Class 2, Special Controls

Product Code KKX Drape, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
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 - KKX Drape, Surgical

All 264
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K833877.
ACU-DERM TRANSPARENT INCISE DRAPE
K841735 · Acme United Corp. · Aug 1984
SPUNGARD & SURG. DRAPES-GOWNS & PACKS
K842115 · Kimberly-Clark Corp. · Jun 1984
ANTIMICROBIAL INCISE DRAPE
K840957 · American Convertors Div., American Pharmaseal · Jun 1984
LIGHT HANDLE COVER
K832278 · Concept, Inc. · Sep 1983
ISOVIS WOUND PROTECTOR
K832874 · Ritmed, Inc. · Sep 1983
ISOVIS WOUND PROTECTOR
K830270 · Ritmed, Inc. · Jun 1983