Cleared Traditional

K933288 - POWDERFREE LATEX EXAMINATION GLOVES

K933288 is an FDA 510(k) clearance for POWDERFREE LATEX EXAMINATION GLOVES, manufactured by Liwe Trading. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 407-day FDA review.

K933288 · Liwe Trading · General Hospital
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Aug 1994
Decision
407d
Days
Class 1
Risk

K933288 is an FDA 510(k) clearance for the POWDERFREE LATEX EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Liwe Trading (Petaling Jaya, MY). The FDA issued a Cleared decision on August 17, 1994 after a review of 407 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Liwe Trading devices

FDA 510(k) Submission Details - K933288

510(k) Number K933288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1993
Decision Date August 17, 1994
Days to Decision 407 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
278d slower than avg
Panel avg: 129d · This submission: 407d
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 585
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K933288.
ROYAL SHIELD NON-STERILE LATEX EXAM GLOVES-BUBBLE GUM
K943043 · Shield Gloves Manufacturer (M) Sdn Bhd · Sep 1994
ROYAL SHIELD NON-STERILE LATEX EXAM GLOVES-STRAWBERRY
K943044 · Shield Gloves Manufacturer (M) Sdn Bhd · Sep 1994
MICRO-TOUCH LATEX MEDICAL GLOVES
K943620 · Johnson & Johnson Medical, Inc. · Sep 1994
SCIPOTEX POWDER FREE EXAM GLOVES (UNBEADED)
K942510 · Wembley Rubber Products (M) Sdn Bhd · Aug 1994
ROYAL SHIELD POWDER-FREE LATEX EXAMANATION GLOVES
K942940 · Shield Gloves Manufacturer (M) Sdn Bhd · Aug 1994
HYPOALLERGEN NON-STER POWDERFREE LATEX PAT EXAM GLOVE
K942758 · Aladan Corp. · Jul 1994