Cleared Traditional

K896165 - STERILE HYPOALLERGENIC SURGEONS' GLOVES

K896165 is the FDA 510(k) clearance for STERILE HYPOALLERGENIC SURGEONS' GLOVES by Isratech Marketing Corp.. It is a Class 1 General Hospital device (product code KGO) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K896165 · Isratech Marketing Corp. · General Hospital
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Nov 1989
Decision
28d
Days
Class 1
Risk

K896165 is an FDA 510(k) clearance for the STERILE HYPOALLERGENIC SURGEONS' GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Isratech Marketing Corp. (New York, US). The FDA issued a Cleared decision on November 22, 1989 after a review of 28 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 Isratech Marketing Corp. devices

Submission Details

510(k) Number K896165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1989
Decision Date November 22, 1989
Days to Decision 28 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 129d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 169
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K896165.
COMFIT SURGEON'S GLOVES
K903446 · Wembley Rubber Products (M) Sdn Bhd · Oct 1990
TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE
K902380 · Baxter Healthcare Corp · Jun 1990
TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE
K897192 · Baxter Healthcare Corp · Feb 1990
BDAC OMICRON PLUS SURGICAL GLOVES
K885271 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1989
REGENT DISPO STERILE BIOGEL STARCH FREE SURG GLOVE
K874099 · Biopro, Inc. · Dec 1987
NEUTRALON SURGICAL GLOVES
K861441 · Surgikos, Inc. · May 1986