Cleared Abbreviated

K080606 - ALATECH POWDERED LATEX PATIENT EXAMINAT...

K080606 is an FDA 510(k) clearance for ALATECH POWDERED LATEX PATIENT EXAMINAT..., manufactured by Alatech Healthcare, LLC. The device is a Class 1 General Hospital device with product code LYY cleared through the Abbreviated 510(k) pathway after a 156-day FDA review.

K080606 · Alatech Healthcare, LLC · General Hospital
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Aug 2008
Decision
156d
Days
Class 1
Risk

K080606 is an FDA 510(k) clearance for the ALATECH POWDERED LATEX PATIENT EXAMINATION GLOVE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Alatech Healthcare, LLC (Eufaula, US). The FDA issued a Cleared decision on August 7, 2008 after a review of 156 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 Alatech Healthcare, LLC devices

FDA 510(k) Submission Details - K080606

510(k) Number K080606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2008
Decision Date August 07, 2008
Days to Decision 156 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
27d slower than avg
Panel avg: 129d · This submission: 156d
Pathway characteristics
Standards-based clearance path.

LYY Device Classification - Class 1, General Controls

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex 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 - LYY Latex Patient Examination Glove

All 293
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K080606.
NON-STERILE, POWDERED LATEX EXAMINATION GLOVE
K081910 · Siam Sempermed Corp., Ltd. · Sep 2008
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 MICROGRAMS OR LESS)
K081907 · Siam Sempermed Corp., Ltd. · Sep 2008
STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIES
K081464 · Cardinalhealth · Aug 2008
NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (200 UG OR LESS)
K072403 · Sgmp Co., Ltd. · Mar 2008
NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (50 UG OR LESS)
K072406 · Sgmp Co., Ltd. · Mar 2008
NON-STERILE, LATEX POWDER FREE PATIENT EXAMINATION GLOVES (MULTICOLORED WITH XYLITOL AND CALCIUM CARBONATE)
K071060 · Sgmp Co., Ltd. · Jul 2007