Cleared Traditional

K953955 - POWDERFREE LATEX EXAM GLOVES WITH PROTEIN CONTENT LABELING CLAIM

K953955 is an FDA 510(k) clearance for POWDERFREE LATEX EXAM GLOVES WITH PROTE..., 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.

K953955 · Codan Medlon, Inc. · General Hospital
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Aug 1996
Decision
371d
Days
Class 1
Risk

K953955 is an FDA 510(k) clearance for the POWDERFREE 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 - K953955

510(k) Number K953955 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 K953955.
MEDLINE PWDER-FREE VIBNYL EXAMIUNATION GLOVES/VINYL GLOVES, STERILE (MDS 192074,5,6)
K962076 · Medline Industries, Inc. · Aug 1996
MEDLINE PRE-POWDERED NON-STERILE AND STERILE LATEX EXAMINATION GLOVES
K962094 · Medline Industries, Inc. · Aug 1996
MEDLINE POWDER-FREE NON-STERILE LATEX EXAMINATION GLOVES,MEDLINE POWDER-FREE STERILE LATEX EXAMINATION GLOVES
K962095 · Medline Industries, Inc. · Aug 1996
BLUE LATEX EXAM GLOVES WITH PROTEIN CONTENT LABELING CLAIM
K953956 · Codan Medlon, Inc. · Aug 1996
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