Cleared Traditional

K002718 - ULTRA CARE 2 LATEX EXAMINATION GLOVES MADE FROM ALLOTEX (ENZYME TREATED) NATURAL RUBBER LATEX WITH A PROTEIN CONTENT LAB

K002718 is an FDA 510(k) clearance for ULTRA CARE 2 LATEX EXAMINATION GLOVES M..., manufactured by Tillotson Healthcare Corp.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K002718 · Tillotson Healthcare Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
243d
Days
Class 1
Risk

K002718 is an FDA 510(k) clearance for the ULTRA CARE 2 LATEX EXAMINATION GLOVES MADE FROM ALLOTEX (ENZYME TREATED) NATU.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Tillotson Healthcare Corp. (Bedford, US). The FDA issued a Cleared decision on May 1, 2001 after a review of 243 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 Tillotson Healthcare Corp. devices

FDA 510(k) Submission Details - K002718

510(k) Number K002718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2000
Decision Date May 01, 2001
Days to Decision 243 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 129d · This submission: 243d
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 813
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K002718.
UNIGLOVE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K010879 · N.S. Uni-Gloves Sdn. Bhd. · May 2001
POWDER-FREE LATEX EXAMINATION GLOVE, BLUE COLORED
K011271 · Perusahaan Getah Asas Sdn. Bhd. · May 2001
POWDERFREE COLORED LATEX EXAMINATION GLOVES (PINK, BLUE, GREEN, AND WHITE) WITH PROTEIN CONTENT LABELING CLAIM (50 MICR0
K010483 · Pt. Medisafe Technologies · May 2001
HEALTH-PLUS, SANITEX, RELIANCE MULTIPLY POWDER FREE POLYMER AND NITRILE COATED (BLUE)
K003350 · Pamitex Industries Sdn Bhd · Apr 2001
LATEX EXAMINATION GLOVES-POWDERED, NONSTERILE
K010347 · Enzymic Technologies Sdn Bhd · Mar 2001
LATEX EXAMINATION GLOVES-POWDER FREE
K010356 · Enzymic Technologies Sdn Bhd · Mar 2001