Cleared Traditional

K053305 - SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE

K053305 is an FDA 510(k) clearance for SENSTOUCH POWDERED 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 186-day FDA review.

K053305 · Pt Mahakarya Inti Buana · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
186d
Days
Class 1
Risk

K053305 is an FDA 510(k) clearance for the SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Pt Mahakarya Inti Buana (Sumut, Indonesia, ID). The FDA issued a Cleared decision on June 2, 2006 after a review of 186 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 - K053305

510(k) Number K053305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2005
Decision Date June 02, 2006
Days to Decision 186 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 129d · This submission: 186d
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 K053305.
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
BRIGHT ELEMENT SND BHD LATEX POWDER FREE EXAMINATION GLOVES
K061078 · Bright Element Sdn Bhd · May 2006
POWDER-FREE LATEX PATIENT EXAMINATION GLOVE,WITH EXTRACTABLE PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAM PER GRAM OF
K060775 · Kossan Latex Industries(M)Sdn Bhd · May 2006
BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE, BLACK COLOR)
K060658 · Brightway Holdings Sdn. Bhd. · Apr 2006
K053305 · SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE
Download PDF FDA Summary Pt Mahakarya Inti Bua…