Cleared Traditional

K102032 - KIMBERLY-CLARK PURPLE NITRILE XTRA* STE...

K102032 is an FDA 510(k) clearance for KIMBERLY-CLARK PURPLE NITRILE XTRA* STE..., manufactured by Kimberly-Clark Corp.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K102032 · Kimberly-Clark Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
51d
Days
Class 1
Risk

K102032 is an FDA 510(k) clearance for the KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHER.... 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 September 8, 2010 after a review of 51 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 Kimberly-Clark Corp. devices

FDA 510(k) Submission Details - K102032

510(k) Number K102032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2010
Decision Date September 08, 2010
Days to Decision 51 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
78d faster than avg
Panel avg: 129d · This submission: 51d
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 682
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K102032.
BRIGHTWAY TM BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE. (GREY COLOR)
K102880 · Brightway Holdings Sdn. Bhd. · Nov 2010
NUGARD NITILE GREY COLOR
K102230 · Terang Nusa Sdn Bhd · Sep 2010
NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR
K101646 · Sgmp Co., Ltd. · Sep 2010
MICRO-TOUCH NITRILE
K093523 · Ansell Healthcare Products, LLC · Mar 2010
MEDIGUARD NITRILE EXAMINATION GLOVE- BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K093726 · Medline Industries, Inc. · Feb 2010
PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)
K092411 · Shen Wei (Usa), Inc. · Oct 2009

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.