Cleared Traditional

K955419 - POWDER FREE TACTYLON SURGEONS GLOVE

K955419 is an FDA 510(k) clearance for POWDER FREE TACTYLON SURGEONS GLOVE, manufactured by Tactyl Technologies, Inc.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K955419 · Tactyl Technologies, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
140d
Days
Class 1
Risk

K955419 is an FDA 510(k) clearance for the POWDER FREE TACTYLON SURGEONS GLOVE. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Tactyl Technologies, Inc. (Vista, US). The FDA issued a Cleared decision on April 15, 1996 after a review of 140 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4460 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Tactyl Technologies, Inc. devices

FDA 510(k) Submission Details - K955419

510(k) Number K955419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1995
Decision Date April 15, 1996
Days to Decision 140 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 129d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

KGO Device Classification - Class 1, General Controls

Product Code KGO Surgeon's Gloves
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4460
Definition A Surgeon's Glove Is A Disposable Device Made Of Natural Rubber Latex Or Synthetic Polymers That May Or May Not Bear Powder To Facilitate Donning, And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KGO Surgeon's Gloves

All 311
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K955419.
COMFIT BROWN, BEADED SURGEON'S GLOVES (POWDERED, HYPOALLERGENIC)
K960178 · Wembley Rubber Products (M) Sdn Bhd · May 1996
COMFIT ORTHOPEDIC
K960407 · Wembley Rubber Products (M) Sdn Bhd · Apr 1996
COMFIT MICROPTIC
K960416 · Wembley Rubber Products (M) Sdn Bhd · Apr 1996
AMPRI
K954002 · Ampri Rubberware Industries Sdn Bhd · Jan 1996
NEUTRALON BROWN LATEX SURGICAL GLOVES
K953639 · Johnson & Johnson Medical, Inc. · Oct 1995
MICRO-TOUCH* LATEX SURGICAL GLOVES
K954049 · Johnson & Johnson Medical, Inc. · Oct 1995