Cleared Traditional

K974518 - NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES COLORED

K974518 is an FDA 510(k) clearance for NON-STERILE POWDER-FREE LATEX EXAMINATI..., 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 10-day FDA review.

K974518 · Yty Industry (Manjung) Sdn Bhd · General Hospital
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Dec 1997
Decision
10d
Days
Class 1
Risk

K974518 is an FDA 510(k) clearance for the NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES COLORED. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Yty Industry (Manjung) Sdn Bhd (Kuala Langat Selangor D.E., MY). The FDA issued a Cleared decision on December 12, 1997 after a review of 10 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 - K974518

510(k) Number K974518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1997
Decision Date December 12, 1997
Days to Decision 10 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
119d faster than avg
Panel avg: 129d · This submission: 10d
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.

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 639
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K974518.
HIGH RISK POLYMER LATEX EXAMINATION GLOVES (BLUE COLOUR)
K974184 · Sri Johani Sdn. Bhd. · Dec 1997
DERMACLEAN STERILE (PROTEIN LABELING CLAIM) EXAM GLOVES
K974218 · Ansell Perry · Dec 1997
POLYMER LATEX EXAMINATION GLOVES
K973904 · Sri Johani 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
POWDER-FREE EXAM GLOVES
K970773 · Pt. Sarana Indoprotex · 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.