Cleared Traditional

LATEX EXAM GLOVE WITH HYPOALLERGENIC LABELING (POWDERED) (K960842) - FDA 510(k) Clearance

Class I General Hospital device.

K960842 · Crocker Industrial Resources Sdn. Bhd. · General Hospital
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Mar 1997
Decision
386d
Days
Class 1
Risk

K960842 is an FDA 510(k) clearance for the LATEX EXAM GLOVE WITH HYPOALLERGENIC LABELING (POWDERED). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Crocker Industrial Resources Sdn. Bhd. (Annapolis Juntion, US). The FDA issued a Cleared decision on March 19, 1997 after a review of 386 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 Crocker Industrial Resources Sdn. Bhd. devices

Submission Details

510(k) Number K960842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1996
Decision Date March 19, 1997
Days to Decision 386 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
257d slower than avg
Panel avg: 129d · This submission: 386d
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 K960842.
SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES)
K171367 · Sanrea Healthcare Products Pvt, Ltd. · Jan 2018
EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) W/ A PROTEIN CONTENT LABEL CLAIM
K103602 · Medline Industries, Inc. · Apr 2011
MEDLINE STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K003055 · Medline Industries, Inc. · Jan 2001
MEDLINE, HYPOALLERGENIC, PRE-POWDERED NON-STERILE AND STERILE LATEX EXAMINATION GLOVES
K962096 · Medline Industries, Inc. · Nov 1996
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