Cleared Traditional

K142190 - Polychloroprene Powder-free Surgical Glove (White) Tested for Use with Chemotherapy Drugs

Also marketed or referenced as:
Polychloroprene Powder-free Surgical Glove (Green) Tested for Use with Chemotherapy Drugs

K142190 is an FDA 510(k) clearance for Polychloroprene Powder-free Surgical Gl..., manufactured by Pt. Medisafe Technologies. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 340-day FDA review.

K142190 · Pt. Medisafe Technologies · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
340d
Days
Class 1
Risk

K142190 is an FDA 510(k) clearance for the Polychloroprene Powder-free Surgical Glove (White) Tested for Use with Chemot.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Pt. Medisafe Technologies (Tanjung Morawa, Medan, ID). The FDA issued a Cleared decision on July 14, 2015 after a review of 340 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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. Medisafe Technologies devices

FDA 510(k) Submission Details - K142190

510(k) Number K142190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2014
Decision Date July 14, 2015
Days to Decision 340 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
211d slower than avg
Panel avg: 129d · This submission: 340d
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 322
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K142190.
Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color.
K142941 · Pt. Medisafe Technologies · Nov 2015
Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less
K151392 · Terang Nusa Sdn Bhd · Sep 2015
Biogel PI Micro Indicator Underglove
K150146 · Molnlycke Health Care Us, LLC · Aug 2015
BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES
K140477 · Molnlycke Health Care Us, LLC · Mar 2015
SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT LABELING CLAIM
K140355 · Terang Nusa Sdn Bhd · Nov 2014
BIOGEL PL MICRO SURGICAL GLOVE
K141719 · Molnlycke Health Care Us, LLC · Sep 2014