Cleared Traditional

K083908 - BLACK NITRILE EXAMINATION GLOVES

K083908 is an FDA 510(k) clearance for BLACK NITRILE EXAMINATION GLOVES, manufactured by Innovative Gloves Co;, Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K083908 · Innovative Gloves Co;, Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
66d
Days
Class 1
Risk

K083908 is an FDA 510(k) clearance for the BLACK NITRILE EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Innovative Gloves Co;, Ltd. (Songkhla, TH). The FDA issued a Cleared decision on March 6, 2009 after a review of 66 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 - K083908

510(k) Number K083908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2008
Decision Date March 06, 2009
Days to Decision 66 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
63d faster than avg
Panel avg: 129d · This submission: 66d
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 K083908.
NON STERILE POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K083156 · Giga-Drive Sdn, Bhd · May 2009
BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE
K090464 · Pt Mahakarya Inti Buana · Apr 2009
BIOCLEAN CHEMO SHIELD
K081970 · Nitritex (M) Sdn. Bhd. · Mar 2009
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR, POLYMER COATED, TEXTED WITH CHEMOTHERAPY DRUGS
K083755 · Siam Sempermed Corp., Ltd. · Mar 2009
N-DEX BWC PINK NITRILE MEDICAL EXAMINATION GLOVE, NON STERILE
K082428 · Best Glove, Inc. · Feb 2009
POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES
K083624 · Comfort Rubber Gloves Ind. Sdn. Bhd. · Feb 2009
K083908 · BLACK NITRILE EXAMINATION GLOVES
Download PDF FDA Summary Innovative Gloves Co;…