Cleared Traditional

K020838 - ULTRA TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)

K020838 is an FDA 510(k) clearance for ULTRA TOUCH POWDER-FREE LATEX EXAMINATI..., manufactured by Ar Alliance Healthcare Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K020838 · Ar Alliance Healthcare Sdn. Bhd. · General Hospital
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Apr 2002
Decision
40d
Days
Class 1
Risk

K020838 is an FDA 510(k) clearance for the ULTRA TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM .... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Ar Alliance Healthcare Sdn. Bhd. (Nibong Tebal, Pulau Pinang, MY). The FDA issued a Cleared decision on April 23, 2002 after a review of 40 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.

View all Ar Alliance Healthcare Sdn. Bhd. devices

FDA 510(k) Submission Details - K020838

510(k) Number K020838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2002
Decision Date April 23, 2002
Days to Decision 40 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 129d · This submission: 40d
Pathway characteristics
Predicate-based equivalence.

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 817
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K020838.
SYNTEX POWDER-FREE LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM
K021059 · Syntex Healthcare Products Co., Ltd. · May 2002
ONLINE POWDER FREE, LATEX EXAMINATION GLOVES
K020865 · Apl Products Sdn. Bhd. · May 2002
SAFE SHIELD POWEDER-FREE LATEX EXAMINATION GLOVES
K020053 · Safe Shield Co., Ltd. · May 2002
GREAT GLOVE LATEX EXAMINATION POWDERFREE GLOVES WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS)
K020363 · Great Glove Sdn Bhd · Apr 2002
LATEX EXAMINATION GLOVES (POWDER FREE)
K014279 · Brightway Gloves Pvt. , Ltd. · Mar 2002
LATEX EXAMINATION GLOVE (POWDERED)
K014280 · Brightway Gloves Pvt. , Ltd. · Mar 2002