Cleared Traditional

K950185 - TACTYLON(TM) POWDER FREE SURGEONS GLOVE

K950185 is an FDA 510(k) clearance for TACTYLON(TM) POWDER FREE 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 86-day FDA review.

K950185 · Tactyl Technologies, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
86d
Days
Class 1
Risk

K950185 is an FDA 510(k) clearance for the TACTYLON(TM) POWDER FREE 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 13, 1995 after a review of 86 days - a notably fast clearance cycle.

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: 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 Tactyl Technologies, Inc. devices

FDA 510(k) Submission Details - K950185

510(k) Number K950185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1995
Decision Date April 13, 1995
Days to Decision 86 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 129d · This submission: 86d
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 313
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K950185.
ULTIMAX
K951473 · Wembley Rubber Products (M) Sdn Bhd · Jul 1995
PROFEEL
K951661 · Wembley Rubber Products (M) Sdn Bhd · May 1995
COMFIT/BEADED SURGEON'S GLOVE
K951662 · Wembley Rubber Products (M) Sdn Bhd · May 1995
SCIPOTEX POWDER FREE SURGICAL GLOVES (BEADED)
K943254 · Wembley Rubber Products (M) Sdn Bhd · Mar 1995
SCIPOTEX POWDER FREE SURGICAL GLOVES (UNBEADED)
K943255 · Wembley Rubber Products (M) Sdn Bhd · Mar 1995
NEUTRALON LP BROWN LATEX SURGICAL GLOVES
K943674 · Maxxim Medical · Feb 1995