Cleared Traditional

K896051 - LONE STAR TRADING SURGICAL GLOVE

K896051 is an FDA 510(k) clearance for LONE STAR TRADING SURGICAL GLOVE, manufactured by Lone Star Trading Pte. , Ltd.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K896051 · Lone Star Trading Pte. , Ltd. · General Hospital
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Nov 1989
Decision
41d
Days
Class 1
Risk

K896051 is an FDA 510(k) clearance for the LONE STAR TRADING SURGICAL GLOVE. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Lone Star Trading Pte. , Ltd. (Huntington Beach, US). The FDA issued a Cleared decision on November 28, 1989 after a review of 41 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 Lone Star Trading Pte. , Ltd. devices

FDA 510(k) Submission Details - K896051

510(k) Number K896051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1989
Decision Date November 28, 1989
Days to Decision 41 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
88d faster than avg
Panel avg: 129d · This submission: 41d
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 376
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K896051.
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
POWDER-FREE/HYPO-ALLERGENIC STERILE SURGEON GLOVES
K895669 · Safeskin Corp. · Nov 1989
SAFESKIN POWDRED HYPOALLERGENIC STERIL SURG GLOVES
K894354 · Safeskin Corp. · Aug 1989
BDAC OMICRON PLUS SURGICAL GLOVES
K885271 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1989