Cleared Traditional

K945766 - HYPOALLERGENIC POWDERED AMBIDEXTROUS PA...

K945766 is the FDA 510(k) clearance for HYPOALLERGENIC POWDERED AMBIDEXTROUS PA... by Ansell, Inc.. It is a Class 1 General Hospital device (product code LYY) cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K945766 · Ansell, Inc. · General Hospital
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Aug 1995
Decision
259d
Days
Class 1
Risk

K945766 is an FDA 510(k) clearance for the HYPOALLERGENIC POWDERED 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 August 7, 1995 after a review of 259 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 Ansell, Inc. devices

Submission Details

510(k) Number K945766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1994
Decision Date August 07, 1995
Days to Decision 259 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
130d slower than avg
Panel avg: 129d · This submission: 259d
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 K945766.
POWDER-FREE LATES EXAM GLOVES WITH PROTEIN CLAIM
K955029 · Shen Wei (Usa), Inc. · Jan 1996
LATEX PATIENT EXAMINATION GLOVE (POWDERFREE/HYPOALLERGENIC) (MODIFICATION)
K954880 · Siam Sempermed Corp., Ltd. · Nov 1995
LATEX PATIENT EXAMINATION GLOVE POWDERFREE LAMINATED COPOLYMER
K951018 · Siam Sempermed Corp., Ltd. · Aug 1995
LATEX PATIENT EXAMINATION GLOVE POWDER FREE (HYPOALLERGENIC)
K946257 · Siam Sempermed Corp., Ltd. · Jun 1995
COMFIT (PINK)
K943601 · Wembley Rubber Products (M) Sdn Bhd · May 1995
COMFIT/GREEN POWDERED EXAMINATION GLOVES
K951667 · Wembley Rubber Products (M) Sdn Bhd · May 1995