Cleared Traditional

K994420 - POWDER FREE LATEX EXAMINATION PATIENT G...

K994420 is the FDA 510(k) clearance for POWDER FREE LATEX EXAMINATION PATIENT G... by Purna Bina Sdn Bhd. It is a Class 1 General Hospital device (product code LYY) cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K994420 · Purna Bina Sdn Bhd · General Hospital
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Sep 2000
Decision
264d
Days
Class 1
Risk

K994420 is an FDA 510(k) clearance for the POWDER FREE LATEX EXAMINATION PATIENT GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Purna Bina Sdn Bhd (Kluang, Johor D. Takzim, MY). The FDA issued a Cleared decision on September 18, 2000 after a review of 264 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 Purna Bina Sdn Bhd devices

Submission Details

510(k) Number K994420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1999
Decision Date September 18, 2000
Days to Decision 264 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 129d · This submission: 264d
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 150
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K994420.
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER
K011044 · Shen Wei (Usa), Inc. · Sep 2001
MEDLINE STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K003055 · Medline Industries, Inc. · Jan 2001
STERILE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)
K003653 · Wrp Asia Pacific Sdn. Bhd. · Jan 2001
POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN P
K001739 · Allegiance Healthcare Corp. · Jul 2000
COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON STERILE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LES
K001280 · Wrp Asia Pacific Sdn. Bhd. · May 2000
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS
K993760 · Hartalega Sdn Bhd · May 2000