Cleared Traditional

K171276 - Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs

K171276 is an FDA 510(k) clearance for Sterile Polyisoprene Surgical Powder Fr..., manufactured by Tg Medical Sdn. Bhd.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K171276 · Tg Medical Sdn. Bhd. · General Hospital
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Aug 2017
Decision
112d
Days
Class 1
Risk

K171276 is an FDA 510(k) clearance for the Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemother.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Tg Medical Sdn. Bhd. (Klang, MY). The FDA issued a Cleared decision on August 21, 2017 after a review of 112 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 - K171276

510(k) Number K171276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2017
Decision Date August 21, 2017
Days to Decision 112 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
17d faster than avg
Panel avg: 129d · This submission: 112d
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 440
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K171276.
Finessis Zero Flexylon Powder Free Sterile White Surgical Glove
K171987 · Lucenxia Prescience AG · Oct 2017
Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves
K171279 · Top Glove Sdn. Bhd. · Oct 2017
Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim
K172420 · Wear Safe Malaysia Sdn. Bhd. · Sep 2017
Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs
K171898 · Better Care Plastic Technology Co., Ltd. · Aug 2017
Sterile Polyisoprene Powder Free Surgical Gloves
K171047 · Better Care Plastic Technology Co., Ltd. · Jun 2017
Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White)
K170198 · Cardinal Health, Inc. · Jun 2017