Cleared Traditional

K121926 - BLUE

K121926 is an FDA 510(k) clearance for BLUE, manufactured by Northstar Healthcare Holdings. The device is a Class 1 General Hospital device with product code LZC cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K121926 · Northstar Healthcare Holdings · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
80d
Days
Class 1
Risk

K121926 is an FDA 510(k) clearance for the BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY .... Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Northstar Healthcare Holdings (Hamilton, Bermuda, IE). The FDA issued a Cleared decision on September 20, 2012 after a review of 80 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 devices

FDA 510(k) Submission Details - K121926

510(k) Number K121926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2012
Decision Date September 20, 2012
Days to Decision 80 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
49d faster than avg
Panel avg: 129d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

LZC Device Classification - Class 1, General Controls

Product Code LZC Medical Glove, Specialty
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Disposable Medical Glove (examination Or Surgeon’s) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc.
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 - LZC Medical Glove, Specialty

All 51
Devices cleared under the same product code (LZC) and FDA review panel - the closest regulatory comparables to K121926.
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM
K162186 · Brightway Holdings Sdn. Bhd. · Mar 2017
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K141982 · Wrp Asia Pacific Sdn. Bhd. · Feb 2015
POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES
K121811 · Shen Wei (Usa), Inc. · Nov 2012
NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U
K120336 · Hartalega Sdn Bhd · Jun 2012
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG
K102790 · Perusahaan Getah Asas Sdn. Bhd. · Nov 2010
NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K101822 · Sgmp Co., Ltd. · Nov 2010