Cleared Traditional

K970613 - PATIENT EXAMINATION GLOVES (POWDER FREE-NON STERILE)

K970613 is an FDA 510(k) clearance for PATIENT EXAMINATION GLOVES (POWDER FREE..., manufactured by Sti Medical Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K970613 · Sti Medical Sdn Bhd · General Hospital
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Mar 1997
Decision
28d
Days
Class 1
Risk

K970613 is an FDA 510(k) clearance for the PATIENT EXAMINATION GLOVES (POWDER FREE-NON STERILE). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Sti Medical Sdn Bhd (Selangor, MY). The FDA issued a Cleared decision on March 18, 1997 after a review of 28 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 Sti Medical Sdn Bhd devices

FDA 510(k) Submission Details - K970613

510(k) Number K970613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1997
Decision Date March 18, 1997
Days to Decision 28 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
101d faster than avg
Panel avg: 129d · This submission: 28d
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 439
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K970613.
LATEX PATIENT EXAMINATION (POWDERFREE GLOVE)
K970794 · Siam Sempermed Corp., Ltd. · May 1997
SAFESKIN POWDERED EXAMINATION GLOVE
K970899 · Safeskin Corp. · May 1997
POLY-MED
K970625 · Shinemound Enterprise, Inc. · Mar 1997
PREPOWDERED LATEX EXAMINATION GLOVE
K970313 · Besglove Healthcare Sdn. Bhd. · Mar 1997
LATEX EXAM GLOVES
K965155 · P.T. Irama Dinamika Latex · Mar 1997
JINHUA LATEX EXAM GLOVE, POWDER FREE WITH PROTEIN LABELING
K964845 · Jinhua Latex Products Factory · Feb 1997