Cleared Abbreviated

K122727 - BLUE STERILE POWDER FREE NITRILE EXAMIN...

K122727 is an FDA 510(k) clearance for BLUE STERILE POWDER FREE NITRILE EXAMIN..., manufactured by Northstar Healthcare Holdings. The device is a Class 1 General Hospital device with product code LZA cleared through the Abbreviated 510(k) pathway after a 170-day FDA review.

K122727 · Northstar Healthcare Holdings · General Hospital
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Feb 2013
Decision
170d
Days
Class 1
Risk

K122727 is an FDA 510(k) clearance for the BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Northstar Healthcare Holdings (Dublin 2, IE). The FDA issued a Cleared decision on February 22, 2013 after a review of 170 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Northstar Healthcare Holdings devices

FDA 510(k) Submission Details - K122727

510(k) Number K122727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2012
Decision Date February 22, 2013
Days to Decision 170 days
Submission Type Abbreviated
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
41d slower than avg
Panel avg: 129d · This submission: 170d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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 702
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K122727.
KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE
K131841 · Kimberly-Clark Corp. · Nov 2013
STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU)
K132006 · Hartalega Sdn Bhd · Nov 2013
NITRILE POWDER FREE EXAMINATION GLOVE (ABLU)
K130473 · Hartalega Sdn Bhd · Jul 2013
POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)
K122696 · Cardinal Health, Inc. · Jan 2013
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE
K121549 · Siam Sempermed Corp., Ltd. · Dec 2012
POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR
K121528 · Shen Wei (Usa), Inc. · Sep 2012