Cleared Traditional

K982589 - SURGEON'S GLOVE

K982589 is an FDA 510(k) clearance for SURGEON'S GLOVE, manufactured by Shiva Medicare , Ltd.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K982589 · Shiva Medicare , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
48d
Days
Class 1
Risk

K982589 is an FDA 510(k) clearance for the SURGEON'S GLOVE. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Shiva Medicare , Ltd. (Baltimore, US). The FDA issued a Cleared decision on September 10, 1998 after a review of 48 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 Shiva Medicare , Ltd. devices

FDA 510(k) Submission Details - K982589

510(k) Number K982589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1998
Decision Date September 10, 1998
Days to Decision 48 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
81d faster than avg
Panel avg: 129d · This submission: 48d
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 294
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K982589.
ENCORE MARK IV POWDER FREE POLYMER COATED LATEX SURGICAL GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE)
K983489 · Ansell Perry · Dec 1998
NEUTRALON PF POWDER FREE BROWN LATEX SURGICAL GLOVES
K983240 · Johnson & Johnson Medical, Div. of Ethicon, Inc. · Nov 1998
SEMPERMED SURGEONS' GLOVES - SUPREME
K981096 · Semperit Technische Produkte Gesellshaft · Oct 1998
OMNI PRO LATEX SURGICAL GLOVE, POWDERED
K982613 · Omnigrace (Thailand) , Ltd. · Sep 1998
POWDER FREE SURGEONS GLOVE
K982586 · Shiva Medicare , Ltd. · Aug 1998
DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES
K980929 · Ansell Perry · Jun 1998