Cleared Traditional

K110185 - NITRILE POWDER FREE PATIENT EXAMINATION GLOVES

K110185 is an FDA 510(k) clearance for NITRILE POWDER FREE PATIENT EXAMINATION..., manufactured by Tangshan Baojie Glove Co., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K110185 · Tangshan Baojie Glove Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
73d
Days
Class 1
Risk

K110185 is an FDA 510(k) clearance for the NITRILE POWDER FREE PATIENT EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Tangshan Baojie Glove Co., Ltd. (Haidian Dis, Beijing, CN). The FDA issued a Cleared decision on April 4, 2011 after a review of 73 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 Tangshan Baojie Glove Co., Ltd. devices

FDA 510(k) Submission Details - K110185

510(k) Number K110185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2011
Decision Date April 04, 2011
Days to Decision 73 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 129d · This submission: 73d
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 775
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K110185.
BLUE POWDERFREE NITRILE EXAMINATION GLOVE
K102623 · Pt. Medisafe Technologies · Jun 2011
SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL
K103770 · Syntex Healthcare Products Co., Ltd. · Apr 2011
NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K110921 · Cardinal Health, Inc. · Apr 2011
NON-STERILE, BLUE & WHITE POWDERED NITRILE EXAMINATION GLOVES
K101820 · Yty Industry (Manjung) Sdn Bhd · Mar 2011
NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUG LABELING CLAIM
K103249 · Cardinal Health, Inc. · Dec 2010
POWDERFREE BLACK NITRILE EXAMINATION GLOVES
K102620 · Pt. Medisafe Technologies · Nov 2010