Cleared Traditional

K943900 - LATEX MEDICAL GLOVE

K943900 is the FDA 510(k) clearance for LATEX MEDICAL GLOVE by Johnson & Johnson Medical, Inc.. It is a Class 1 General Hospital device (product code LYY) cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K943900 · Johnson & Johnson Medical, Inc. · General Hospital
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Dec 1994
Decision
124d
Days
Class 1
Risk

K943900 is an FDA 510(k) clearance for the LATEX MEDICAL GLOVE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Johnson & Johnson Medical, Inc. (Arlington, US). The FDA issued a Cleared decision on December 12, 1994 after a review of 124 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 Johnson & Johnson Medical, Inc. devices

Submission Details

510(k) Number K943900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1994
Decision Date December 12, 1994
Days to Decision 124 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 129d · This submission: 124d
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 149
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K943900.
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
SCIPOTEX
K943868 · Wembley Rubber Products (M) Sdn Bhd · Feb 1995
COMFIT BLUE POWDERED EXAMINATION GLOVES
K936268 · Wembley Rubber Products (M) Sdn Bhd · Dec 1994
COMFIT
K944140 · Wembley Rubber Products (M) Sdn Bhd · Dec 1994
COMFIT EXAMINATION GLOVES, POWDER FREE, HYPOALLERGENIC
K942947 · Wembley Rubber Products (M) Sdn Bhd · Nov 1994