Cleared Abbreviated

K081911 - NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE

K081911 is an FDA 510(k) clearance for NON-STERILE, manufactured by Siam Sempermed Corp., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Abbreviated 510(k) pathway after a 196-day FDA review.

K081911 · Siam Sempermed Corp., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
196d
Days
Class 1
Risk

K081911 is an FDA 510(k) clearance for the NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Siam Sempermed Corp., Ltd. (Clearwater, US). The FDA issued a Cleared decision on January 15, 2009 after a review of 196 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Siam Sempermed Corp., Ltd. devices

FDA 510(k) Submission Details - K081911

510(k) Number K081911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2008
Decision Date January 15, 2009
Days to Decision 196 days
Submission Type Abbreviated
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
67d slower than avg
Panel avg: 129d · This submission: 196d
Pathway characteristics
Standards-based clearance path.

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 761
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K081911.
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLOR, POLYMER COATED, TESTED WITH CHEMOTHERAPY DRUGS
K082957 · Siam Sempermed Corp., Ltd. · May 2009
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR, POLYMER COATED, TEXTED WITH CHEMOTHERAPY DRUGS
K083755 · Siam Sempermed Corp., Ltd. · Mar 2009
POWDER FREE NITRILE EXAMINATION GLOVES, BUBBLE GUM SCENTED, PINK
K083717 · Gx Corporation Sdn Bhd · Jan 2009
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM
K082302 · Pt. Medisafe Technologies · Dec 2008
MEDLINE POWDER-FREE NITRILE EXAMINATION GLOVE WITH ALOE
K081594 · Medline Industries, Inc. · Oct 2008
POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
K082370 · Smart Glove Corp. Sdn Bhd · Oct 2008