Cleared Traditional

K072145 - MEDICAL GLOVE SERIES

K072145 is an FDA 510(k) clearance for MEDICAL GLOVE SERIES, manufactured by Zhanjiang Jiali Glove Products Co., Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K072145 · Zhanjiang Jiali Glove Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
208d
Days
Class 1
Risk

K072145 is an FDA 510(k) clearance for the MEDICAL GLOVE SERIES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Zhanjiang Jiali Glove Products Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on February 26, 2008 after a review of 208 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.

View all Zhanjiang Jiali Glove Products Co., Ltd. devices

FDA 510(k) Submission Details - K072145

510(k) Number K072145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2007
Decision Date February 26, 2008
Days to Decision 208 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 129d · This submission: 208d
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 551
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K072145.
STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIES
K081464 · Cardinalhealth · Aug 2008
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