Cleared Traditional

K063581 - SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE

K063581 is an FDA 510(k) clearance for SENSTOUCH HIGH RISK BLUE LATEX EXAMINAT..., 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 105-day FDA review.

K063581 · Pt Mahakarya Inti Buana · General Hospital
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Mar 2007
Decision
105d
Days
Class 1
Risk

K063581 is an FDA 510(k) clearance for the SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Pt Mahakarya Inti Buana (Tanjung Morawa, Sumut, ID). The FDA issued a Cleared decision on March 15, 2007 after a review of 105 days - within the typical 510(k) review window.

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.

View all Pt Mahakarya Inti Buana devices

FDA 510(k) Submission Details - K063581

510(k) Number K063581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2006
Decision Date March 15, 2007
Days to Decision 105 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 129d · This submission: 105d
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 405
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K063581.
NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (200 UG OR LESS)
K072403 · Sgmp Co., Ltd. · Mar 2008
NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (50 UG OR LESS)
K072406 · Sgmp Co., Ltd. · Mar 2008
NON-STERILE, LATEX POWDER FREE PATIENT EXAMINATION GLOVES (MULTICOLORED WITH XYLITOL AND CALCIUM CARBONATE)
K071060 · Sgmp Co., Ltd. · Jul 2007
CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM
K062965 · Kossan Latex Industries(M)Sdn Bhd · Dec 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