Cleared Traditional

K130667 - POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL

K130667 is an FDA 510(k) clearance for POWDERFREE LATEX EXAMINATION GLOVES COA..., manufactured by Preventive Care, Inc.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K130667 · Preventive Care, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
134d
Days
Class 1
Risk

K130667 is an FDA 510(k) clearance for the POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Preventive Care, Inc. (Rosemount, US). The FDA issued a Cleared decision on July 24, 2013 after a review of 134 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 Preventive Care, Inc. devices

FDA 510(k) Submission Details - K130667

510(k) Number K130667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2013
Decision Date July 24, 2013
Days to Decision 134 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
5d slower than avg
Panel avg: 129d · This submission: 134d
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 633
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K130667.
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M
K133953 · Hartalega Sdn Bhd · May 2014
POWDER FREE LATEX EXAMINATION GLOVES
K123537 · Qube Medical Product Sdn Bhd · Feb 2014
POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES
K121844 · Worldmed Manufacturing Sdn. Bhd. · Sep 2013
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT
K123368 · Hartalega Sdn Bhd · May 2013
MULTIPLE NAME
K123819 · Top Calibre Sdn Bhd · Mar 2013
POWDER FREE LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM, NATURAL COLOR
K123757 · Assurguard Sdn. Bhd. · Feb 2013