Cleared Traditional

K942855 - NON-CHLORINATED POWDER FREE LATEX EXAMI...

K942855 is an FDA 510(k) clearance for NON-CHLORINATED POWDER FREE LATEX EXAMI..., manufactured by Evergrade Healthcare Products Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 517-day FDA review.

K942855 · Evergrade Healthcare Products Sdn Bhd · General Hospital
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Nov 1995
Decision
517d
Days
Class 1
Risk

K942855 is an FDA 510(k) clearance for the NON-CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Evergrade Healthcare Products Sdn Bhd (Muar Johor, MY). The FDA issued a Cleared decision on November 15, 1995 after a review of 517 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 Evergrade Healthcare Products Sdn Bhd devices

FDA 510(k) Submission Details - K942855

510(k) Number K942855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1994
Decision Date November 15, 1995
Days to Decision 517 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
388d slower than avg
Panel avg: 129d · This submission: 517d
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 294
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K942855.
PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
K954415 · Hartalega Sdn Bhd · Mar 1996
POWDER-FREE LATES EXAM GLOVES WITH PROTEIN CLAIM
K955029 · Shen Wei (Usa), Inc. · Jan 1996
POWDER FREE LATEX EXAMINATION GLOVES
K954365 · Perusahaan Getah Asas Sdn. Bhd. · Dec 1995
LATEX PATIENT EXAMINATION GLOVE (POWDERFREE/HYPOALLERGENIC) (MODIFICATION)
K954880 · Siam Sempermed Corp., Ltd. · Nov 1995
HYPOALLERGENIC POWDERED AMBIDEXTROUS COAGULATN DIPPED LATEX EXAMINATION GLOVE
K953379 · Ansell, Inc. · Sep 1995
LATEX PATIENT EXAMINATION GLOVE POWDERFREE LAMINATED COPOLYMER
K951018 · Siam Sempermed Corp., Ltd. · Aug 1995