Cleared Traditional

K945247 - POWDERFREE LATEX EXAMINATION GLOVE

K945247 is an FDA 510(k) clearance for POWDERFREE LATEX EXAMINATION GLOVE, 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 67-day FDA review.

K945247 · Sri Johani Sdn. Bhd. · General Hospital
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Jan 1995
Decision
67d
Days
Class 1
Risk

K945247 is an FDA 510(k) clearance for the POWDERFREE LATEX EXAMINATION GLOVE. 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 January 2, 1995 after a review of 67 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 - K945247

510(k) Number K945247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1994
Decision Date January 02, 1995
Days to Decision 67 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
62d faster than avg
Panel avg: 129d · This submission: 67d
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 K945247.
ULTIMAX (GREEN POWDER FREE EXAMINATION)
K943869 · Wembley Rubber Products (M) Sdn Bhd · Feb 1995
SCIPOTEX POWDER FREE EXAM GLOVES (BEADED)
K942511 · Wembley Rubber Products (M) Sdn Bhd · Feb 1995
SCIPOTEX
K943868 · Wembley Rubber Products (M) Sdn Bhd · Feb 1995
LATEX MEDICAL GLOVE
K943900 · Johnson & Johnson Medical, Inc. · Dec 1994
COMFIT BLUE POWDERED EXAMINATION GLOVES
K936268 · Wembley Rubber Products (M) Sdn Bhd · Dec 1994
COMFIT
K944140 · Wembley Rubber Products (M) Sdn Bhd · Dec 1994