Cleared Traditional

K945767 - POWDER FREE

K945767 is the FDA 510(k) clearance for POWDER FREE by Ansell, Inc.. It is a Class 1 General Hospital device (product code LYY) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K945767 · Ansell, Inc. · General Hospital
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Mar 1995
Decision
101d
Days
Class 1
Risk

K945767 is an FDA 510(k) clearance for the POWDER FREE, HYPOALLERGENIC AMBIDEXTROUS PATIENT EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Ansell, Inc. (Dothan, US). The FDA issued a Cleared decision on March 2, 1995 after a review of 101 days - within the typical 510(k) review window.

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 Ansell, Inc. devices

Submission Details

510(k) Number K945767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1994
Decision Date March 02, 1995
Days to Decision 101 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
28d faster than avg
Panel avg: 129d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 151
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K945767.
SCIPOTEX
K951171 · Wembley Rubber Products (M) Sdn Bhd · Apr 1995
PATIENT EXAMINATION GLOVES
K945885 · Hartalega Sdn Bhd · Mar 1995
COMFIT BLUE POWDER FREE EXAMINATION GLOVES
K943563 · Wembley Rubber Products (M) Sdn Bhd · Mar 1995
ULTIMAX POWDER FREE EXAMINATION GLOVES
K943451 · Wembley Rubber Products (M) Sdn Bhd · Feb 1995
ULTIMAX (GREEN POWDER FREE EXAMINATION)
K943869 · Wembley Rubber Products (M) Sdn Bhd · Feb 1995
SCIPOTEX POWDER FREE EXAM GLOVES (BEADED)
K942511 · Wembley Rubber Products (M) Sdn Bhd · Feb 1995