Cleared Traditional

K954221 - POLYMER COATED CHLORINATED POWDER-FREE ...

K954221 is the FDA 510(k) clearance for POLYMER COATED CHLORINATED POWDER-FREE ... by Hartalega Sdn Bhd. It is a Class 1 General Hospital device (product code LYY) cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K954221 · Hartalega Sdn Bhd · General Hospital
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May 1996
Decision
235d
Days
Class 1
Risk

K954221 is an FDA 510(k) clearance for the POLYMER COATED CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Hartalega Sdn Bhd (Kuala Lumpur, MY). The FDA issued a Cleared decision on May 3, 1996 after a review of 235 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Hartalega Sdn Bhd devices

Submission Details

510(k) Number K954221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1995
Decision Date May 03, 1996
Days to Decision 235 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
106d slower than avg
Panel avg: 129d · This submission: 235d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 124
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K954221.
COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)
K962188 · Wembley Rubber Products (M) Sdn Bhd · Jul 1996
COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)
K962189 · Wembley Rubber Products (M) Sdn Bhd · Jul 1996
COMFIT
K953590 · Wembley Rubber Products (M) Sdn Bhd · Jun 1996
PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
K954415 · Hartalega Sdn Bhd · Mar 1996
POWDER-FREE LATES EXAM GLOVES WITH PROTEIN CLAIM
K955029 · Shen Wei (Usa), Inc. · Jan 1996
COMFIT (PINK)
K943601 · Wembley Rubber Products (M) Sdn Bhd · May 1995