Cleared Traditional

K953958 - POWDERFREE BLUE LATEX EXAM GLOVES WITH PROTEIN CONTENT LABELING CLAIM

K953958 is an FDA 510(k) clearance for POWDERFREE BLUE LATEX EXAM GLOVES WITH ..., manufactured by Codan Medlon, Inc.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 371-day FDA review.

K953958 · Codan Medlon, Inc. · General Hospital
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Aug 1996
Decision
371d
Days
Class 1
Risk

K953958 is an FDA 510(k) clearance for the POWDERFREE BLUE LATEX EXAM GLOVES WITH PROTEIN CONTENT LABELING CLAIM. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Codan Medlon, Inc. (Chester, US). The FDA issued a Cleared decision on August 20, 1996 after a review of 371 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Codan Medlon, Inc. devices

FDA 510(k) Submission Details - K953958

510(k) Number K953958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1995
Decision Date August 20, 1996
Days to Decision 371 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
242d slower than avg
Panel avg: 129d · This submission: 371d
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 628
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K953958.
MEDLINE POWDER-FREE NON-STERILE LATEX EXAMINATION GLOVES,MEDLINE POWDER-FREE STERILE LATEX EXAMINATION GLOVES
K962095 · Medline Industries, Inc. · Aug 1996
POWDERFREE LATEX EXAM GLOVES WITH PROTEIN CONTENT LABELING CLAIM
K953955 · Codan Medlon, Inc. · Aug 1996
BLUE LATEX EXAM GLOVES WITH PROTEIN CONTENT LABELING CLAIM
K953956 · 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
POWDER FREE PLUS HYPOALLERGENIC (WITH LABELED PROTEIN CONTENT) PATIENT EXAMINATION GLOVES
K960225 · Tillotson Healthcare Corp. · Jul 1996