Cleared Traditional

K201829 - SensiCare PI Evolution Surgical Glove (...

K201829 is the FDA 510(k) clearance for SensiCare PI Evolution Surgical Glove (... by Medline Industries, Inc.. It is a Class 1 General Hospital device (product code KGO) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K201829 · Medline Industries, Inc. · General Hospital
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Sep 2020
Decision
69d
Days
Class 1
Risk

K201829 is an FDA 510(k) clearance for the SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs). 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 September 9, 2020 after a review of 69 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medline Industries, Inc. devices

Submission Details

510(k) Number K201829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2020
Decision Date September 09, 2020
Days to Decision 69 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
60d faster than avg
Panel avg: 129d · This submission: 69d
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 K201829.
Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable Protein
K202449 · Medline Industries, Inc. · Nov 2020
Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs
K201748 · Hartalega Sdn Bhd · Oct 2020
Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs
K201774 · Pt. Medisafe Technologies · Sep 2020
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