Cleared Traditional

K191915 - SensiCare Sterile Power-Free Polymer Co...

K191915 is the FDA 510(k) clearance for SensiCare Sterile Power-Free Polymer Co... by Medline Industries, Inc.. It is a Class 1 General Hospital device (product code KGO) cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K191915 · Medline Industries, Inc. · General Hospital
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Mar 2020
Decision
233d
Days
Class 1
Risk

K191915 is an FDA 510(k) clearance for the SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coate.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Cleared decision on March 6, 2020 after a review of 233 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 K191915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2019
Decision Date March 06, 2020
Days to Decision 233 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
104d slower than avg
Panel avg: 129d · This submission: 233d
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 K191915.
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
SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs)
K192820 · Medline Industries, Inc. · Feb 2020
Sterile Latex Surgical Glove, Powder Free
K190241 · Careglove Global Sdn. Bhd. · Dec 2019
Sterile Latex Powder-Free Surgical Gloves
K191898 · Modern Healthcare Corp. · Dec 2019