Cleared Traditional

K971514 - REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE

K971514 is an FDA 510(k) clearance for REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE, manufactured by London International Group, Inc.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K971514 · London International Group, Inc. · General Hospital
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Oct 1997
Decision
187d
Days
Class 1
Risk

K971514 is an FDA 510(k) clearance for the REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by London International Group, Inc. (Dotham, US). The FDA issued a Cleared decision on October 29, 1997 after a review of 187 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - 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 London International Group, Inc. devices

FDA 510(k) Submission Details - K971514

510(k) Number K971514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1997
Decision Date October 29, 1997
Days to Decision 187 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 129d · This submission: 187d
Pathway characteristics
Predicate-based equivalence.

LYY Device Classification - Class 1, General Controls

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes 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 - LYY Latex Patient Examination Glove

All 441
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K971514.
HIGH RISK POWDERED LATEX EXAMINATION GLOVES (BLUE COLOUR)
K973815 · Sri Johani Sdn. Bhd. · Nov 1997
Hi Coat Powder Free Latex Patient Examination Gloves
K972539 · P.T. Latexindo Tobaperkasa · Nov 1997
OMNI F.T. LATEX EXAMINATION GLOVE, POWDERED
K973134 · Omnigrace , Ltd. · Nov 1997
ALLIANCE RUBBER, EC-GRIP
K972801 · Alliance Rubber Products Sdn. Bhd. · Oct 1997
POWDER-FREE LATEX EXAMINATION GLOVE, TEAL OR WHITE (NON-COLORED)
K973811 · Absolute Quality Leadership, Inc. · Oct 1997
CONFORM NO POWDER (PROTEIN LABELING CLAIM) EXAMINATION GLOVES
K972785 · Ansell Perry · Sep 1997