Cleared Traditional

POWDER-FREE LATEX EXAM GLOVE W/HYPOALLERGENIC CLAIM (K960841) - FDA 510(k) Clearance

Class I General Hospital device.

K960841 · Boston Medical Corp. · General Hospital
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Aug 1996
Decision
170d
Days
Class 1
Risk

K960841 is an FDA 510(k) clearance for the POWDER-FREE LATEX EXAM GLOVE W/HYPOALLERGENIC CLAIM. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Boston Medical Corp. (Annapolis Junction, US). The FDA issued a Cleared decision on August 15, 1996 after a review of 170 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 Boston Medical Corp. devices

Submission Details

510(k) Number K960841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1996
Decision Date August 15, 1996
Days to Decision 170 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
41d slower than avg
Panel avg: 129d · This submission: 170d
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 42
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K960841.
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
PATIENT EXAMINATION GLOVES (LATEX)
K894022 · Baxter Healthcare Corp · Aug 1989
B-D PATIENT EXAMINATION GLOVES
K894280 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1989
ACCU-TOUCH LATEX EXAM GLOVES, UNISIZE & LARGE
K891791 · Medline Industries, Inc. · Jul 1989