Cleared Traditional

K960225 - POWDER FREE PLUS HYPOALLERGENIC (WITH LABELED PROTEIN CONTENT) PATIENT EXAMINATION GLOVES

K960225 is an FDA 510(k) clearance for POWDER FREE PLUS HYPOALLERGENIC (WITH L..., 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 194-day FDA review.

K960225 · Tillotson Healthcare Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
194d
Days
Class 1
Risk

K960225 is an FDA 510(k) clearance for the POWDER FREE PLUS HYPOALLERGENIC (WITH LABELED PROTEIN CONTENT) PATIENT EXAMIN.... 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 July 29, 1996 after a review of 194 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 - K960225

510(k) Number K960225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1996
Decision Date July 29, 1996
Days to Decision 194 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
65d slower than avg
Panel avg: 129d · This submission: 194d
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 833
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K960225.
POWDERFREE BLUE LATEX EXAM GLOVES WITH PROTEIN CONTENT LABELING CLAIM
K953958 · Codan Medlon, Inc. · Aug 1996
POWDER-FREE LATEX EXAM GLOVE W/HYPOALLERGENIC CLAIM
K960841 · Boston Medical Corp. · Aug 1996
PATIENT LATEX EXAMINATION GLOVES (POWDERED, NON STERILE)
K962650 · Sti Medical Sdn Bhd · Aug 1996
ULTRA CARE POWDER FREE HYPOALLERGENIC PATIENT EXAMINATION GLOVE
K960247 · Tillotson Healthcare Corp. · Jul 1996
PATIENT EXAMINATION GLOVE (POWDERED)
K954293 · Medline Products Co. , Ltd. · Jul 1996
COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)
K962188 · Wembley Rubber Products (M) Sdn Bhd · Jul 1996