Cleared Traditional

K960842 - LATEX EXAM GLOVE WITH HYPOALLERGENIC LABELING (POWDERED)

K960842 is an FDA 510(k) clearance for LATEX EXAM GLOVE WITH HYPOALLERGENIC LA..., manufactured by Crocker Industrial Resources Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 386-day FDA review.

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

FDA 510(k) Submission Details - K960842

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.

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 489
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K960842.
LATEX PATIENT EXAMINATION (POWDERFREE GLOVE)
K970794 · Siam Sempermed Corp., Ltd. · May 1997
SAFESKIN POWDERED EXAMINATION GLOVE
K970899 · Safeskin Corp. · May 1997
POLY-MED
K970625 · Shinemound Enterprise, Inc. · Mar 1997
PATIENT EXAMINATION GLOVES (POWDER FREE-NON STERILE)
K970613 · Sti Medical Sdn Bhd · Mar 1997
PREPOWDERED LATEX EXAMINATION GLOVE
K970313 · Besglove Healthcare Sdn. Bhd. · Mar 1997
LATEX EXAM GLOVES
K965155 · P.T. Irama Dinamika Latex · Mar 1997