Cleared Traditional

K980942 - REGENT BIOGEL INDICATOR INNER SURGICAL GLOVE

K980942 is an FDA 510(k) clearance for REGENT BIOGEL INDICATOR INNER SURGICAL ..., manufactured by London International Group, Inc.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K980942 · London International Group, Inc. · General Hospital
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May 1998
Decision
60d
Days
Class 1
Risk

K980942 is an FDA 510(k) clearance for the REGENT BIOGEL INDICATOR INNER SURGICAL GLOVE. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by London International Group, Inc. (Dotham, US). The FDA issued a Cleared decision on May 11, 1998 after a review of 60 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 London International Group, Inc. devices

FDA 510(k) Submission Details - K980942

510(k) Number K980942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1998
Decision Date May 11, 1998
Days to Decision 60 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 129d · This submission: 60d
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 283
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K980942.
ENCORE MARK IV POWDER FREE POLYMER COATED LATEX SURGICAL GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE)
K983489 · Ansell Perry · Dec 1998
DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES
K980929 · Ansell Perry · Jun 1998
SENSI-DERM LATEX SURGICAL GLOVES (POWDERED)
K980880 · Ansell Perry · May 1998
ELITE MARK IV POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE
K981392 · Ansell Perry · May 1998
MEDI-GRIP (BEIGE 43)SURGICAL GLOVES
K980564 · Ansell Perry · Mar 1998
ELASTYREN POWDER-FREE SURGICAL GLOVE
K971471 · Eci Medical Technologies, Inc. · Feb 1998