Cleared Traditional

K061233 - SENSTOUCH POWDER FREE EXAMINATION GLOVES, NON STERILE

K061233 is an FDA 510(k) clearance for SENSTOUCH POWDER FREE EXAMINATION GLOVES, manufactured by Pt Mahakarya Inti Buana. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K061233 · Pt Mahakarya Inti Buana · General Hospital
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Nov 2006
Decision
185d
Days
Class 1
Risk

K061233 is an FDA 510(k) clearance for the SENSTOUCH POWDER FREE EXAMINATION GLOVES, NON STERILE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Pt Mahakarya Inti Buana (Morawa, Sumut, ID). The FDA issued a Cleared decision on November 3, 2006 after a review of 185 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K061233

510(k) Number K061233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2006
Decision Date November 03, 2006
Days to Decision 185 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
56d slower than avg
Panel avg: 129d · This submission: 185d
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 1286
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K061233.
SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE
K062313 · Pt Mahakarya Inti Buana · Nov 2006
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
STERILE AND NON-STERILE POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRACTABLE PROTEIN CONTENT LABELING CLAIM (50
K062917 · Wear Safe Malaysia Sdn. Bhd. · 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
K061233 · SENSTOUCH POWDER FREE EXAMINATION GLOVES, NON STERILE
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