Cleared Traditional

K173258 - Polychloroprene Powder Free Sterile Sur...

K173258 is the FDA 510(k) clearance for Polychloroprene Powder Free Sterile Sur... by Pt. Medisafe Technologies. It is a Class 1 General Hospital device (product code KGO) cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K173258 · Pt. Medisafe Technologies · General Hospital
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Apr 2018
Decision
192d
Days
Class 1
Risk

K173258 is an FDA 510(k) clearance for the Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use wi.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Pt. Medisafe Technologies (Medan, ID). The FDA issued a Cleared decision on April 20, 2018 after a review of 192 days - an extended review cycle.

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.

View all Pt. Medisafe Technologies devices

Submission Details

510(k) Number K173258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2017
Decision Date April 20, 2018
Days to Decision 192 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
63d slower than avg
Panel avg: 129d · This submission: 192d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 143
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K173258.
Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs
K180221 · Smart Glove Corporation Sdn. Bhd. · Aug 2018
Sterile Latex Surgical Gloves, Powder Free
K171550 · Sanrea Healthcare Products Pvt, Ltd. · Jul 2018
Finessis Intense Polyisoprene Surgical Glove
K173304 · Lucenxia Prescience AG · Apr 2018
Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs
K173386 · Lucenxia Prescience AG · Apr 2018
Gammex PI Breach Detect Powder Free Surgical Glove
K171375 · Ansell Healthcare Products, LLC · Feb 2018
Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein
K172942 · Beta Healthcare Products Pvt., Ltd. · Jan 2018