Cleared Traditional

K932283 - PATIENT EXAMINATION GLOVES

K932283 is an FDA 510(k) clearance for PATIENT EXAMINATION GLOVES, manufactured by Eac Rubber Industries (M) Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 360-day FDA review.

K932283 · Eac Rubber Industries (M) Sdn. Bhd. · General Hospital
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May 1994
Decision
360d
Days
Class 1
Risk

K932283 is an FDA 510(k) clearance for the PATIENT EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Eac Rubber Industries (M) Sdn. Bhd. (Malaysia, MY). The FDA issued a Cleared decision on May 2, 1994 after a review of 360 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Eac Rubber Industries (M) Sdn. Bhd. devices

FDA 510(k) Submission Details - K932283

510(k) Number K932283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1993
Decision Date May 02, 1994
Days to Decision 360 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
231d slower than avg
Panel avg: 129d · This submission: 360d
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 709
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K932283.
LATEX PATIENT EXAMINATION GLOVE
K940022 · Siam Sempermed Corp., Ltd. · May 1994
COMFIT POWERED EXAMINATION GLOVES(BEADED, HYPOALLERG)
K935866 · Wembley Rubber Products (M) Sdn Bhd · May 1994
POWDERED EXAMINATION GLOVES (HYPOALLERGENIC)
K935864 · Wembley Rubber Products (M) Sdn Bhd · May 1994
SAFETEX HYPOALLERGENIC POWDERFREE LATEX EXAMINATION GLOVE
K940873 · Aladan Corp. · Apr 1994
POWDER-FREE LATEX EXAMINATION GLOVES
K935812 · Shen Wei (Usa), Inc. · Mar 1994
COMFIT POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC)
K935852 · Wembley Rubber Products (M) Sdn Bhd · Mar 1994