Cleared Abbreviated

K122727 - BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE

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
Combination Product No
PCCP Authorized No
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 Consultant

Underwriters Laboratories, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LZA Polymer Patient Examination Glove

All 1167
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K122727.
MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, GREY
K122453 · Industrial Clothings, Ltd. · Apr 2013
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE
K123749 · Kossan Latex Industries(M)Sdn Bhd · Mar 2013
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
K123869 · Dehai (Shandong) Medical Gloves, Co., Ltd. · Feb 2013
POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE
K130038 · Hl Rubber Industries Sdn Bhd · Feb 2013
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILE
K123469 · Wear Safe (Malaysia) Sdn Bhd - Facility II · Feb 2013
CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR)
K123116 · Worldmed Manufacturing Sdn. Bhd. · Feb 2013

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.