Cleared Traditional

K951908 - REGENT BIOGEL LATEX-FREE SURGEON'S GLOVE

K951908 is an FDA 510(k) clearance for REGENT BIOGEL LATEX-FREE SURGEON'S GLOVE, manufactured by Regent Hospital Products. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K951908 · Regent Hospital Products · General Hospital
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Sep 1995
Decision
130d
Days
Class 1
Risk

K951908 is an FDA 510(k) clearance for the REGENT BIOGEL LATEX-FREE SURGEON'S GLOVE. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Regent Hospital Products (Washington, US). The FDA issued a Cleared decision on September 1, 1995 after a review of 130 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Regent Hospital Products devices

FDA 510(k) Submission Details - K951908

510(k) Number K951908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1995
Decision Date September 01, 1995
Days to Decision 130 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
1d slower than avg
Panel avg: 129d · This submission: 130d
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 371
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K951908.
NEUTRALON BROWN LATEX SURGICAL GLOVES
K953639 · Johnson & Johnson Medical, Inc. · Oct 1995
MICRO-TOUCH* LATEX SURGICAL GLOVES
K954049 · Johnson & Johnson Medical, Inc. · Oct 1995
MAXXUS ORTHOPAEDIC SURGICAL GLOVES
K953641 · Johnson & Johnson Medical, Inc. · Sep 1995
SAFESKIN SUPRA
K952993 · Safeskin Corp. · Aug 1995
SAFESKIN SUPRA
K953015 · Safeskin Corp. · Aug 1995
ULTIMAX
K951473 · Wembley Rubber Products (M) Sdn Bhd · Jul 1995