Cleared Traditional

K994420 - POWDER FREE LATEX EXAMINATION PATIENT GLOVES

K994420 is an FDA 510(k) clearance for POWDER FREE LATEX EXAMINATION PATIENT G..., manufactured by Purna Bina Sdn Bhd. The device is a Class 1 General Hospital device with 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.

FDA 510(k) Submission Details - K994420

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 129d · This submission: 264d
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 1953
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K994420.
DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K000838 · P.T. Healthcare Glovindo · Oct 2000
OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (200 MICROGRAMS OR LESS)
K002922 · Omnigrace (Thailand) , Ltd. · Oct 2000
POLYMER COAT, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K002568 · Smart Glove Corp. Sdn Bhd · Oct 2000
MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDERED
K000141 · Industrial Clothings, Ltd. · Sep 2000
MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDER FREE
K000142 · Industrial Clothings, Ltd. · Sep 2000
BESTEX POWDER-FREE LATEX EXAM GLOVES WITH LABELING CLAIM. (50 MICROGRAMS OR LESS)
K002087 · Qingdao Bestex Rubber & Plastic Products Co., Ltd. · Sep 2000
K994420 · POWDER FREE LATEX EXAMINATION PATIENT GLOVES
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