Cleared Traditional

K042817 - MICRO-TOUCH SMOOTH NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE)

K042817 is an FDA 510(k) clearance for MICRO-TOUCH SMOOTH NITRILE POWDER-FREE ..., manufactured by Ansell Healthcare Products, Inc.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K042817 · Ansell Healthcare Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
55d
Days
Class 1
Risk

K042817 is an FDA 510(k) clearance for the MICRO-TOUCH SMOOTH NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY .... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Ansell Healthcare Products, Inc. (Dothan, US). The FDA issued a Cleared decision on December 6, 2004 after a review of 55 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 Ansell Healthcare Products, Inc. devices

FDA 510(k) Submission Details - K042817

510(k) Number K042817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2004
Decision Date December 06, 2004
Days to Decision 55 days
Submission Type Traditional
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
74d faster than avg
Panel avg: 129d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

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 1164
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K042817.
PANTHERA N POWDER FREE BLACK NITRILE GLOVES
K042898 · Glovco (M) Sdn. Bhd. · Jan 2005
NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES, WITH VANILLA SCENTING
K042879 · Sgmp Co., Ltd. · Jan 2005
FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERILE
K042239 · Pt. Mandiri Inti Buana · Dec 2004
POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATION GLOVES TESTED FOR CHEMO USE
K041913 · Pt. Medisafe Technologies · Dec 2004
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPY
K042226 · Syntex Healthcare Products Co., Ltd. · Sep 2004
NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE
K042378 · Shijiazhuang Tillotson Rubber Products Co., Ltd. · Sep 2004