Cleared Abbreviated

K052890 - NON-STERILE POWDER-FREE NITRILE EXAMINA...

K052890 is the FDA 510(k) clearance for NON-STERILE POWDER-FREE NITRILE EXAMINA... by Siam Sempermed Corp., Ltd.. It is a Class 1 General Hospital device (product code LZA) cleared through the Abbreviated 510(k) pathway after a 18-day FDA review.

K052890 · Siam Sempermed Corp., Ltd. · General Hospital
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Oct 2005
Decision
18d
Days
Class 1
Risk

K052890 is an FDA 510(k) clearance for the NON-STERILE POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, WITH VITAMIN E. 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 October 31, 2005 after a review of 18 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 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

Submission Details

510(k) Number K052890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2005
Decision Date October 31, 2005
Days to Decision 18 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 129d · This submission: 18d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 498
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K052890.
KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES
K081260 · Kimberly-Clark Corp. · Jul 2008
KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE)
K081027 · Kimberly-Clark Corp. · Jun 2008
BLUE COLOUR POWDER FREE BARRIERPRO POLYMER BP2000 POLYBUTADIENE COPOLYMER EXAMINATION GLOVES
K061192 · Ethicon Endo-Surgery, LLC · May 2006
KIMBERLY-CLARK* STERLING* NITRILE POWDER-FREE EXAMINATION GLOVE
K051347 · Kimberly-Clark Corp. · Jun 2005
POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K040841 · Medline Industries, Inc. · Jul 2004
SAFESKIN NEON NITRILE - POWDER FREE NEON EXAM GLOVE
K011713 · Kimberly-Clark Corp. · Jul 2001