Cleared Traditional

K974191 - EVERGREEN NON-STERILE POWDERED LATEX EX...

K974191 is an FDA 510(k) clearance for EVERGREEN NON-STERILE POWDERED LATEX EX..., manufactured by Yty Industry (Manjung) Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K974191 · Yty Industry (Manjung) Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
44d
Days
Class 1
Risk

K974191 is an FDA 510(k) clearance for the EVERGREEN NON-STERILE POWDERED LATEX EXAMINATION GLOVE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Yty Industry (Manjung) Sdn Bhd (Sparks, US). The FDA issued a Cleared decision on December 24, 1997 after a review of 44 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 Yty Industry (Manjung) Sdn Bhd devices

FDA 510(k) Submission Details - K974191

510(k) Number K974191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1997
Decision Date December 24, 1997
Days to Decision 44 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 129d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 Consultant

Met Laboratories, Inc.
LEONARD FRIER

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LYY Latex Patient Examination Glove

All 225
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K974191.
LATEX EXAMINATION GLOVE POWDER FREE
K974870 · Smart Glove Corp. Sdn Bhd · Mar 1998
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN)
K980572 · Hartalega Sdn Bhd · Mar 1998
POWDER-FREE LATEX EXAMINATION GLOVES (BLUE)
K980318 · Hartalega Sdn Bhd · Mar 1998
NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES COLORED
K974518 · Yty Industry (Manjung) Sdn Bhd · Dec 1997
POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES
K973778 · Hartalega Sdn Bhd · Dec 1997
LOW POWDER POLYMER LATEX EXAMINATION GLOVES (WITH PROTEIN LABELING CLAIM)
K973871 · Hartalega Sdn Bhd · Dec 1997

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.