Cleared Traditional

K122696 - POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)

K122696 is an FDA 510(k) clearance for POWDER-FREE NITRILE EXAMINATION GLOVES ..., manufactured by Cardinal Health, Inc.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K122696 · Cardinal Health, Inc. · General Hospital
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Jan 2013
Decision
149d
Days
Class 1
Risk

K122696 is an FDA 510(k) clearance for the POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Cardinal Health, Inc. (Waukegan, US). The FDA issued a Cleared decision on January 31, 2013 after a review of 149 days - within the typical 510(k) review window.

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 Cardinal Health, Inc. devices

FDA 510(k) Submission Details - K122696

510(k) Number K122696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2012
Decision Date January 31, 2013
Days to Decision 149 days
Submission Type Traditional
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
20d slower than avg
Panel avg: 129d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. 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.
NED DEVINE

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 1073
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K122696.
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
LINSHI NITRILE DISPOSABLE EXAM GLOVES, POWDER-FREE
K123488 · Puyang Linshi Health Co., Ltd. · Feb 2013
MULTIPLE NAME
K123760 · Assurguard Sdn. Bhd. · Jan 2013
POWDER FREE BLUE NITRILE EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS
K121592 · Tekmedic (M) Sdn Bhd · Jan 2013
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK
K123328 · Nitrilist Gloves Manufacturing Sdn Bhd · Jan 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.