Cleared Traditional

K974184 - HIGH RISK POLYMER LATEX EXAMINATION GLO...

K974184 is an FDA 510(k) clearance for HIGH RISK POLYMER LATEX EXAMINATION GLO..., manufactured by Sri Johani Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K974184 · Sri Johani Sdn. Bhd. · General Hospital
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Dec 1997
Decision
42d
Days
Class 1
Risk

K974184 is an FDA 510(k) clearance for the HIGH RISK POLYMER LATEX EXAMINATION GLOVES (BLUE COLOUR). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Sri Johani Sdn. Bhd. (Selangor, MY). The FDA issued a Cleared decision on December 18, 1997 after a review of 42 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 Sri Johani Sdn. Bhd. devices

FDA 510(k) Submission Details - K974184

510(k) Number K974184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1997
Decision Date December 18, 1997
Days to Decision 42 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 129d · This submission: 42d
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 264
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K974184.
POWDERFREE GREEN LATEX EXAMINATION GLOVES
K980038 · Sri Johani Sdn. Bhd. · Feb 1998
POWDERED GREEN LATEX EXAMINATION GLOVES
K980039 · Sri Johani Sdn. Bhd. · Feb 1998
EVERGREEN NON-STERILE POWDERED LATEX EXAMINATION GLOVE
K974191 · Yty Industry (Manjung) Sdn Bhd · Dec 1997
POLYMER LATEX EXAMINATION GLOVES
K973904 · Sri Johani Sdn. Bhd. · Dec 1997
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