Cleared Traditional

K002448 - LATEX EXAMINATION GLOVES, POWDERED, (CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM).

K002448 is an FDA 510(k) clearance for LATEX EXAMINATION GLOVES, manufactured by Oon Corp. Resources. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K002448 · Oon Corp. Resources · General Hospital
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Sep 2000
Decision
33d
Days
Class 1
Risk

K002448 is an FDA 510(k) clearance for the LATEX EXAMINATION GLOVES, POWDERED, (CONTAINS 100 MICROGRAMS OR LESS OF TOTAL.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Oon Corp. Resources (Seremban, MY). The FDA issued a Cleared decision on September 11, 2000 after a review of 33 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.

FDA 510(k) Submission Details - K002448

510(k) Number K002448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2000
Decision Date September 11, 2000
Days to Decision 33 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
96d faster than avg
Panel avg: 129d · This submission: 33d
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 K002448.
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
POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM. (50 MICROGRAMS OR LESS)
K002701 · Alliance Rubber Products Sdn. Bhd. · Sep 2000
RUBBERCARE POLYMER-COATED POWDERED LATEX EXAMINATION GLOVES/GUARDIAN POLYMER-COATED POWDERED EXAMINATION GLOVES. CONTAI
K002111 · Perusahaan Pelindung Getah (M) Sdn Bhd · Sep 2000
DERMAGRIP POWDERFREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS)
K002579 · Wrp Specialty Products Sdn. Bhd. · Sep 2000
PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GR
K002065 · Comfort Rubber Gloves Industries Sdn. Bhd. · Aug 2000
K002448 · LATEX EXAMINATION GLOVES, POWDERED, (CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM).
Download PDF Oon Corp. Resources