Cleared Traditional

K192988 - Dermasure Green Sterile SyntheticPolych...

K192988 is the FDA 510(k) clearance for Dermasure Green Sterile SyntheticPolych... by Medline Industries, Inc.. It is a Class 1 General Hospital device (product code KGO) cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K192988 · Medline Industries, Inc. · General Hospital
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Apr 2020
Decision
159d
Days
Class 1
Risk

K192988 is an FDA 510(k) clearance for the Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove T.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Medline Industries, Inc. (Northfield, US). The FDA issued a Cleared decision on April 1, 2020 after a review of 159 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 Medline Industries, Inc. devices

Submission Details

510(k) Number K192988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2019
Decision Date April 01, 2020
Days to Decision 159 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
30d slower than avg
Panel avg: 129d · This submission: 159d
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 164
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K192988.
Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)
K200897 · Hartalega Sdn Bhd · Jun 2020
Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro
K193573 · Molnlycke Health Care Us, LLC · Apr 2020
SensiCare PI and SensiCare PI Micro Surgical Gloves
K193217 · Medline Industries, Inc. · Apr 2020
Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential
K191860 · Semperit Technische Produkte Gesellchaft M.B.H. · Mar 2020
Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim
K191869 · Molnlycke Health Care Us, LLC · Mar 2020
JR.MEDIK Latex Surgeon’s Gloves Powder Free
K192328 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · Mar 2020