Cleared Traditional

K861441 - NEUTRALON SURGICAL GLOVES

K861441 is an FDA 510(k) clearance for NEUTRALON SURGICAL GLOVES, manufactured by Surgikos, Inc.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K861441 · Surgikos, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1986
Decision
43d
Days
Class 1
Risk

K861441 is an FDA 510(k) clearance for the NEUTRALON SURGICAL GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Surgikos, Inc. (Arlington, US). The FDA issued a Cleared decision on May 30, 1986 after a review of 43 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 Surgikos, Inc. devices

FDA 510(k) Submission Details - K861441

510(k) Number K861441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1986
Decision Date May 30, 1986
Days to Decision 43 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 129d · This submission: 43d
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 290
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K861441.
SAFESKIN STERILE SURGEONS GLOVES
K880446 · Safeskin Corp. · Jun 1988
REGENT DISPO STERILE BIOGEL STARCH FREE SURG GLOVE
K874099 · Biopro, Inc. · Dec 1987
LATEX SURGICAL GLOVES
K864064 · Futuremed Div. of Future Impex Corp. · Oct 1986
ANSELL NO POWDER SURGEON'S GLOVES
K850635 · Ansell, Inc. · Jun 1985
SURGEON'S GLOVES
K842884 · Travenol Laboratories, S.A. · Nov 1984
VANISH
K833976 · Parke-Davis Co. · Feb 1984