Cleared Traditional

K140988 - POWDER FREE STERILE LATEX SURGICAL GLOVE, YELLOW COLOR (BRAND NAME: TITANFINE)

K140988 is an FDA 510(k) clearance for POWDER FREE STERILE LATEX SURGICAL GLOVE, manufactured by Hebei Hongsen Plastics Technology Co, Ltd.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K140988 · Hebei Hongsen Plastics Technology Co, Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
117d
Days
Class 1
Risk

K140988 is an FDA 510(k) clearance for the POWDER FREE STERILE LATEX SURGICAL GLOVE, YELLOW COLOR (BRAND NAME: TITANFINE). Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Hebei Hongsen Plastics Technology Co, Ltd. (New Milford, US). The FDA issued a Cleared decision on August 12, 2014 after a review of 117 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4460 - 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 - K140988

510(k) Number K140988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2014
Decision Date August 12, 2014
Days to Decision 117 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
12d faster than avg
Panel avg: 129d · This submission: 117d
Pathway characteristics
Predicate-based equivalence.

KGO Device Classification - Class 1, General Controls

Product Code KGO Surgeon's Gloves
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4460
Definition A Surgeon's Glove Is A Disposable Device Made Of Natural Rubber Latex Or Synthetic Polymers That May Or May Not Bear Powder To Facilitate Donning, And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, 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 - KGO Surgeon's Gloves

All 439
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K140988.
SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT LABELING CLAIM
K140355 · Terang Nusa Sdn Bhd · Nov 2014
SURGTEX POWDERED SURGICAL GLOVE, SURGTEX POWDERFREE POLYMER COATED SURGICAL GLOVE
K130450 · Purna Bina Sdn Bhd · Sep 2014
BIOGEL PL MICRO SURGICAL GLOVE
K141719 · Molnlycke Health Care Us, LLC · Sep 2014
MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532)
K123126 · Shanghai Motex Healthcare Co., Ltd. · Jun 2014
MOTEX POWDERED NITRILE SURGICAL GLOVES
K132802 · Shanghai Motex Healthcare Co., Ltd. · May 2014
MOTEX POWDER-FREE NITRILE SURGICAL GLOVES
K122557 · Shanghai Motex Healthcare Co., Ltd. · Oct 2013