Cleared Traditional

K893522 - SURGEON'S GLOVES

K893522 is an FDA 510(k) clearance for SURGEON'S GLOVES, manufactured by Thai Fuji Latex Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FGO cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K893522 · Thai Fuji Latex Co., Ltd. · Gastroenterology & Urology device
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Jan 1990
Decision
259d
Days
Class 2
Risk

K893522 is an FDA 510(k) clearance for the SURGEON'S GLOVES. Classified as Dislodger, Stone, Flexible (product code FGO), Class II - Special Controls.

Submitted by Thai Fuji Latex Co., Ltd. (San Francisco, US). The FDA issued a Cleared decision on January 22, 1990 after a review of 259 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4680 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Thai Fuji Latex Co., Ltd. devices

FDA 510(k) Submission Details - K893522

510(k) Number K893522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1989
Decision Date January 22, 1990
Days to Decision 259 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 130d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGO Device Classification - Class 2, Special Controls

Product Code FGO Dislodger, Stone, Flexible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4680
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FGO Dislodger, Stone, Flexible

All 9
Devices cleared under the same product code (FGO) and FDA review panel - the closest regulatory comparables to K893522.
GRASPING FORCEPS
K933261 · Surgitek · Jan 1994
INTRAVENOUS CATHETERS MODIFICATIONS
K921295 · Critikon Company, LLC · May 1993
GRASPING FORCEPS
K922542 · Surgitek · Aug 1992
RUBENSTEIN URETERAL STONE FRAGMENT BRUSH
K885168 · Boston Scientific Corp · Sep 1989
PFISTER-SCHWARTZ STONE RETRIEVER
K771302 · V. Mueller O.V. Baxter Healthcare Corp. · Aug 1977