Cleared Traditional

K112988 - POWDER FREE LATEX PATIENT EXAM GLOVE WI...

K112988 is an FDA 510(k) clearance for POWDER FREE LATEX PATIENT EXAM GLOVE WI..., manufactured by Northstar Healthcare Holdings Limited. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K112988 · Northstar Healthcare Holdings Limited · General Hospital
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Nov 2011
Decision
34d
Days
Class 1
Risk

K112988 is an FDA 510(k) clearance for the POWDER FREE LATEX PATIENT EXAM GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRA.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Northstar Healthcare Holdings Limited (Mc Henry, US). The FDA issued a Cleared decision on November 9, 2011 after a review of 34 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Northstar Healthcare Holdings Limited devices

FDA 510(k) Submission Details - K112988

510(k) Number K112988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2011
Decision Date November 09, 2011
Days to Decision 34 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 129d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 293
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K112988.
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