Cleared Traditional

K941056 - LATEX EXAMINATION GLOVES, POWDER FREE

K941056 is an FDA 510(k) clearance for LATEX EXAMINATION GLOVES, manufactured by Pt. Eka Wira Asia. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K941056 · Pt. Eka Wira Asia · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
57d
Days
Class 1
Risk

K941056 is an FDA 510(k) clearance for the LATEX EXAMINATION GLOVES, POWDER FREE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Pt. Eka Wira Asia (Medan 20112 - Indonesia, ID). The FDA issued a Cleared decision on April 29, 1994 after a review of 57 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.

View all Pt. Eka Wira Asia devices

FDA 510(k) Submission Details - K941056

510(k) Number K941056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1994
Decision Date April 29, 1994
Days to Decision 57 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 129d · This submission: 57d
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 487
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K941056.
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