Cleared Traditional

K112612 - POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM

K112612 is an FDA 510(k) clearance for POWDER FREE LATEX PATIENT EXAMINATION GLOVE, manufactured by Top Calibre Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K112612 · Top Calibre Sdn Bhd · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
133d
Days
Class 1
Risk

K112612 is an FDA 510(k) clearance for the POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Top Calibre Sdn Bhd (Shah Alam, MY). The FDA issued a Cleared decision on January 18, 2012 after a review of 133 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.

FDA 510(k) Submission Details - K112612

510(k) Number K112612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2011
Decision Date January 18, 2012
Days to Decision 133 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
4d slower than avg
Panel avg: 129d · This submission: 133d
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 1120
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K112612.
LATEX EXAMINATION GLOVES (POWDER FREE)
K120692 · Top Calibre Sdn Bhd · May 2012
LATEX EXAMINATION GLOVES (POWDERED)
K120693 · Top Calibre Sdn Bhd · May 2012
NON-STERILE, POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K112005 · Ug Healthcare (Usa), Inc. · Mar 2012
POWDER FREE LATEX PATIENT EXAM GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS PER DM SQUARED OR LESS OF WATER SOLUBLE
K112988 · Northstar Healthcare Holdings Limited · Nov 2011
SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
K111923 · Pt. Intan Hevea Industry · Nov 2011
MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES
K110250 · Total Gloves Sdn Bhd · Oct 2011