Cleared Abbreviated

K081027 - KIMBERLY-CLARK STERLING NITRILE POWDER-...

K081027 is an FDA 510(k) clearance for KIMBERLY-CLARK STERLING NITRILE POWDER-..., manufactured by Kimberly-Clark Corp.. The device is a Class 1 General Hospital device with product code LZA cleared through the Abbreviated 510(k) pathway after a 81-day FDA review.

K081027 · Kimberly-Clark Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
81d
Days
Class 1
Risk

K081027 is an FDA 510(k) clearance for the KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Kimberly-Clark Corp. (Roswell, US). The FDA issued a Cleared decision on June 30, 2008 after a review of 81 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 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 Kimberly-Clark Corp. devices

FDA 510(k) Submission Details - K081027

510(k) Number K081027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2008
Decision Date June 30, 2008
Days to Decision 81 days
Submission Type Abbreviated
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
48d faster than avg
Panel avg: 129d · This submission: 81d
Pathway characteristics
Standards-based clearance path.

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 682
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K081027.
POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
K082370 · Smart Glove Corp. Sdn Bhd · Oct 2008
STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K081466 · Smart Glove Corp. Sdn Bhd · Jul 2008
KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES
K081260 · Kimberly-Clark Corp. · Jul 2008
MICRO-TOUCH NITRAFREE
K080536 · Ansell Healthcare Products, LLC · Jun 2008
NON STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, POLYMER COATING WITH CHEMOTHERAPY CLAIM
K080520 · Siam Sempermed Corp., Ltd. · Apr 2008
NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES
K072400 · Sgmp Co., Ltd. · Mar 2008