Cleared Traditional

K984249 - SKINSENSE NITRILE POWDER-FREE SYNTHETIC MEDICAL EXAMINATION GLOVE

K984249 is an FDA 510(k) clearance for SKINSENSE NITRILE POWDER-FREE SYNTHETIC..., manufactured by London International Group, Inc.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K984249 · London International Group, Inc. · General Hospital
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May 1999
Decision
155d
Days
Class 1
Risk

K984249 is an FDA 510(k) clearance for the SKINSENSE NITRILE POWDER-FREE SYNTHETIC MEDICAL EXAMINATION GLOVE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by London International Group, Inc. (Dothan, US). The FDA issued a Cleared decision on May 4, 1999 after a review of 155 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 London International Group, Inc. devices

FDA 510(k) Submission Details - K984249

510(k) Number K984249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1998
Decision Date May 04, 1999
Days to Decision 155 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
26d slower than avg
Panel avg: 129d · This submission: 155d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers 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 - LZA Polymer Patient Examination Glove

All 779
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K984249.
LAGLOVE BRAND COLORED NITRILE EXAMINATION GLOVES (POWDER FREE)
K990882 · La Glove (M) Sdn. Bhd. · May 1999
NUGARD NITRIL POWDERFREE NITRILE EXAMINATION GLOVE
K990840 · Terang Nusa Sdn Bhd · May 1999
NUGARD NITRIL NITRILE EXAMINATION GLOVE
K990841 · Terang Nusa Sdn Bhd · May 1999
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE)
K990541 · Brightway Holdings Sdn. Bhd. · Apr 1999
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)
K990542 · Brightway Holdings Sdn. Bhd. · Apr 1999
LAGLOVE BRAND NITRILE EXAMINATION GLOVES (LIGHTLY POWDERED)
K990415 · La Glove (M) Sdn. Bhd. · Mar 1999