Cleared Traditional

K011497 - CYMUN-NBR POWDER FREE BLUE NITRILE EXAM...

K011497 is an FDA 510(k) clearance for CYMUN-NBR POWDER FREE BLUE NITRILE EXAM..., manufactured by Tillotson Healthcare Corp.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K011497 · Tillotson Healthcare Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
56d
Days
Class 1
Risk

K011497 is an FDA 510(k) clearance for the CYMUN-NBR POWDER FREE BLUE NITRILE EXAMINATION GLOVE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Tillotson Healthcare Corp. (Bedford, US). The FDA issued a Cleared decision on July 10, 2001 after a review of 56 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 Tillotson Healthcare Corp. devices

FDA 510(k) Submission Details - K011497

510(k) Number K011497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2001
Decision Date July 10, 2001
Days to Decision 56 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
73d faster than avg
Panel avg: 129d · This submission: 56d
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 702
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K011497.
SMART GLOVE STERILE NITRILE EXAM GLOVE
K012853 · Smart Glove Corp. Sdn Bhd · Nov 2001
POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS E PH5.5
K011961 · Shen Wei (Usa), Inc. · Sep 2001
POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE
K012048 · Wrp Asia Pacific Sdn. Bhd. · Aug 2001
DERMASAFE CHEMO PLUS POWDER FREE NEOPRENE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K011482 · Wrp Asia Pacific Sdn. Bhd. · Jul 2001
SAFESKIN NEON NITRILE - POWDER FREE NEON EXAM GLOVE
K011713 · Kimberly-Clark Corp. · Jul 2001
LAGLOVE BRAND NITROPRENE POWDER FREE EXAMINATION GLOVES (MADE OF NITRILE-NEOPRENE CO-POLYMER)
K010863 · La Glove (M) Sdn. Bhd. · May 2001