Cleared Traditional

K062917 - STERILE AND NON-STERILE POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRACTABLE PROTEIN CONTENT LABELING CLAIM (50

K062917 is an FDA 510(k) clearance for STERILE AND NON-STERILE POWDER-FREE LAT..., manufactured by Wear Safe Malaysia Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K062917 · Wear Safe Malaysia Sdn. Bhd. · General Hospital
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Nov 2006
Decision
35d
Days
Class 1
Risk

K062917 is an FDA 510(k) clearance for the STERILE AND NON-STERILE POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXT.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Wear Safe Malaysia Sdn. Bhd. (Port Klang, Selangor, D.E., MY). The FDA issued a Cleared decision on November 2, 2006 after a review of 35 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.

FDA 510(k) Submission Details - K062917

510(k) Number K062917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2006
Decision Date November 02, 2006
Days to Decision 35 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
94d faster than avg
Panel avg: 129d · This submission: 35d
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 1134
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K062917.
POWDER-FREE BLACK LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM
K062688 · Ug Healthcare (Usa), Inc. · Nov 2006
POWDER FREE LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
K062955 · Pt. Haloni Jane · Nov 2006
SENSTOUCH POWDER FREE EXAMINATION GLOVES, NON STERILE
K061233 · Pt Mahakarya Inti Buana · Nov 2006
POWDER FREE LATEX EXAMINATION GLOVES, NATURAL OR BLUE COLOUR AND WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS)
K061551 · Medipure Corporation (M) Sdn. Bhd. · Aug 2006
LATEX POWDERED EXAMINATION GLOVE
K060858 · High Momentum Sdn Bhd · Jun 2006
SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE
K053305 · Pt Mahakarya Inti Buana · Jun 2006