Cleared Special

K010211 - STERILE NITRILE POWDER-FREE EXAMINATION...

K010211 is an FDA 510(k) clearance for STERILE NITRILE POWDER-FREE EXAMINATION..., manufactured by Allegiance Healthcare Corp.. The device is a Class 1 General Hospital device with product code LZC cleared through the Special 510(k) pathway after a 23-day FDA review.

K010211 · Allegiance Healthcare Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
23d
Days
Class 1
Risk

K010211 is an FDA 510(k) clearance for the STERILE NITRILE POWDER-FREE EXAMINATION GLOVES. Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Allegiance Healthcare Corp. (Mcgraw Park, US). The FDA issued a Cleared decision on February 15, 2001 after a review of 23 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Allegiance Healthcare Corp. devices

FDA 510(k) Submission Details - K010211

510(k) Number K010211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2001
Decision Date February 15, 2001
Days to Decision 23 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 129d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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 50
Devices cleared under the same product code (LZC) and FDA review panel - the closest regulatory comparables to K010211.
LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING
K033789 · Cardinalhealth · May 2004
NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY
K032444 · Cardinalhealth · Nov 2003
POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED
K032374 · Perusahaan Getah Asas Sdn. Bhd. · Oct 2003
SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM
K992162 · Safeskin Corp. · Aug 1999
NITRILE GLOVES
K970135 · Sage Products, Inc. · Aug 1997
FLUORO-SHIELD RADIATION REDUCTION GLOVES
K920620 · Acufex Microsurgical, Inc. · Jun 1993