Cleared Traditional

K001858 - OPERATING ROOM TOWEL, STERILE, COLORS BLUE OR WHITE

K001858 is an FDA 510(k) clearance for OPERATING ROOM TOWEL, manufactured by China Nantong Guangda Textile Co., Ltd.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K001858 · China Nantong Guangda Textile Co., Ltd. · General Hospital
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Aug 2000
Decision
59d
Days
Class 2
Risk

K001858 is an FDA 510(k) clearance for the OPERATING ROOM TOWEL, STERILE, COLORS BLUE OR WHITE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by China Nantong Guangda Textile Co., Ltd. (Bartlett, US). The FDA issued a Cleared decision on August 17, 2000 after a review of 59 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 China Nantong Guangda Textile Co., Ltd. devices

FDA 510(k) Submission Details - K001858

510(k) Number K001858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2000
Decision Date August 17, 2000
Days to Decision 59 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
70d faster than avg
Panel avg: 129d · This submission: 59d
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 263
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K001858.
PATIENT DRAPE, SURGICAL
K003670 · Advance Medical Designs, Inc. · Jan 2001
NEUROTOLOGY DRAPE, MODEL TBD
K002702 · Gyrus Ent LLC · Oct 2000
EQUIPMENT DRAPES
K002508 · Allegiance Healthcare Corp. · Sep 2000
RESOLVE SURGICAL O.R. TOWELS
K001667 · Allegiance Healthcare Corp. · Jun 2000
VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPES, ABSOR
K994199 · Custom Medical Products, Inc. · Jun 2000
CONVERTORS EQUIPMENT DRAPES
K000417 · Allegiance Healthcare Corp. · Mar 2000