Cleared Traditional

SURGEON'S GLOVES (K893522) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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.