Cleared Traditional

K000351 - HANWELLA LATEX PATIENT EXAM. GLOVES POWDER-FREE

K000351 is an FDA 510(k) clearance for HANWELLA LATEX PATIENT EXAM. GLOVES POW..., manufactured by Hanwella Rubber Products , Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K000351 · Hanwella Rubber Products , Ltd. · General Hospital
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Jun 2000
Decision
140d
Days
Class 1
Risk

K000351 is an FDA 510(k) clearance for the HANWELLA LATEX PATIENT EXAM. GLOVES POWDER-FREE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Hanwella Rubber Products , Ltd. (Colombo 2, LK). The FDA issued a Cleared decision on June 23, 2000 after a review of 140 days - within the typical 510(k) review window.

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 Hanwella Rubber Products , Ltd. devices

FDA 510(k) Submission Details - K000351

510(k) Number K000351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2000
Decision Date June 23, 2000
Days to Decision 140 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
11d slower than avg
Panel avg: 129d · This submission: 140d
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 634
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K000351.
POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN P
K001739 · Allegiance Healthcare Corp. · Jul 2000
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE COLOR
K000952 · Pamitex Industries Sdn Bhd · Jun 2000
POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR
K001674 · Pamitex Industries Sdn Bhd · Jun 2000
POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES
K001672 · Pamitex Industries Sdn Bhd · Jun 2000
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIM, CONTAINS 50 MICROGRAMS OR LESS OF TOTA
K001529 · Perusahaan Getah Asas Sdn. Bhd. · Jun 2000
LAXTEX POWDERED EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS)
K001557 · Kossan Latex Industries(M)Sdn Bhd · Jun 2000