Cleared Traditional

K111589 - POWDER FREE NITRILE PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP A SKIN PROTECTANT DRUG

K111589 is an FDA 510(k) clearance for POWDER FREE NITRILE PATIENT EXAMINATION..., manufactured by Derma Care Plus Products, LLC. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K111589 · Derma Care Plus Products, LLC · General Hospital
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Aug 2011
Decision
77d
Days
Class 1
Risk

K111589 is an FDA 510(k) clearance for the POWDER FREE NITRILE PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP A SK.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Derma Care Plus Products, LLC (Green Bay, US). The FDA issued a Cleared decision on August 23, 2011 after a review of 77 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.

FDA 510(k) Submission Details - K111589

510(k) Number K111589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2011
Decision Date August 23, 2011
Days to Decision 77 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 129d · This submission: 77d
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 1177
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K111589.
DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE,TESTED FOR USE W/ CHEMOTHERAPY DRUGS
K110979 · Advanced Medical Products Sdn Bhd · Oct 2011
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE
K111772 · Kossan Latex Industries(M)Sdn Bhd · Oct 2011
CHIENMAX VIETNAM CO. LTD POWDER FREE BLUE NITRILE EXAMINATION GLOVE
K103675 · Chienmax Vietnam Co., Ltd. · Oct 2011
POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE
K103734 · Central Medicare Sdn Bhd · Aug 2011
NITRILE POWDER FREE EXAMINATION GLOVES
K110758 · Hartalega Sdn Bhd · Aug 2011
SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN, ORANGE, VIOLET AND WHITE)
K111300 · Pt Mahakarya Inti Buana · Aug 2011
K111589 · POWDER FREE NITRILE PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP A SKIN PROTECTANT DRUG
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