Cleared Traditional

K011791 - POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR

K011791 is an FDA 510(k) clearance for POWDER FREE NITRILE EXAMINATION GLOVES, manufactured by Latexx Partners Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K011791 · Latexx Partners Bhd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
54d
Days
Class 1
Risk

K011791 is an FDA 510(k) clearance for the POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Latexx Partners Bhd. (Crofton, US). The FDA issued a Cleared decision on August 1, 2001 after a review of 54 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 - K011791

510(k) Number K011791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2001
Decision Date August 01, 2001
Days to Decision 54 days
Submission Type Traditional
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
75d faster than avg
Panel avg: 129d · This submission: 54d
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 K011791.
SUNMAX BLUE NITRILE POWDER-FREE EXAMINATION GLOVE
K011765 · Sunmax Enterprise Shanghai Co. , Ltd. · Aug 2001
POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE
K012048 · Wrp Asia Pacific Sdn. Bhd. · Aug 2001
SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES
K011717 · Sunmax Enterprise Shanghai Co. , Ltd. · Aug 2001
NON-CHLORINATED, POLYMER COATED POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
K011792 · Latexx Partners Bhd. · Aug 2001
NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BROWN)
K012166 · Best Manufacturing Company · Aug 2001
CYMUN-NBR POWDER FREE BLUE NITRILE EXAMINATION GLOVE
K011497 · Tillotson Healthcare Corp. · Jul 2001
K011791 · POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR
Download PDF FDA Summary Latexx Partners Bhd.