Cleared Traditional

KOSAN ANGEL LATEX SURGICAL GLOVES (STERILE) (K890311) - FDA 510(k) Clearance

Class I General Hospital device.

K890311 · Kosan Far East Ent. , Ltd. · General Hospital
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Mar 1989
Decision
39d
Days
Class 1
Risk

K890311 is an FDA 510(k) clearance for the KOSAN ANGEL LATEX SURGICAL GLOVES (STERILE). Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Kosan Far East Ent. , Ltd. (Hong Kong, TW). The FDA issued a Cleared decision on March 3, 1989 after a review of 39 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 Kosan Far East Ent. , Ltd. devices

Submission Details

510(k) Number K890311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1989
Decision Date March 03, 1989
Days to Decision 39 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
90d faster than avg
Panel avg: 129d · This submission: 39d
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 97
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K890311.
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
SURGEON'S GLOVES
K842884 · Travenol Laboratories, S.A. · Nov 1984
TRIFLEX SURGEON'S GLOVES
K832448 · Travenol Laboratories, S.A. · Jan 1984
RADIATION STERILIZED SURGEON'S GLOVES
K813565 · Travenol Laboratories, S.A. · Jan 1982