Cleared Traditional

K023912 - POWDER FREE LATEX SURGEON'S GLOVES CONT...

K023912 is an FDA 510(k) clearance for POWDER FREE LATEX SURGEON'S GLOVES CONT..., manufactured by Sanrea Healthcare Private Limited. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K023912 · Sanrea Healthcare Private Limited · General Hospital
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Feb 2003
Decision
78d
Days
Class 1
Risk

K023912 is an FDA 510(k) clearance for the POWDER FREE LATEX SURGEON'S GLOVES CONTAINS 50 MEGM OR LESS OF TOTAL WATER EX.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Sanrea Healthcare Private Limited (Kerala, IN). The FDA issued a Cleared decision on February 11, 2003 after a review of 78 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 Sanrea Healthcare Private Limited devices

FDA 510(k) Submission Details - K023912

510(k) Number K023912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2002
Decision Date February 11, 2003
Days to Decision 78 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 129d · This submission: 78d
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 261
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K023912.
ALOETOUCH POWDER FREE NEOPRENE SURGICAL GLOVES, STERILE, TURQUOISE COLOUR AND COATED WITH ALOE VERA
K032647 · Wrp Asia Pacific Sdn. Bhd. · Nov 2003
ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING
K031301 · Cardinalhealth · Oct 2003
ALOETOUCH POWDER FREE LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING CLAIM (50
K032464 · Wrp Asia Pacific Sdn. Bhd. · Aug 2003
POWDER FREE POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, STERILE
K024130 · Wrp Asia Pacific Sdn. Bhd. · Dec 2002
SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES
K023236 · Maxxim Medical · Nov 2002
POWDER FREE GREEN NEOPRENE SURGICAL GLOVES, STERILE WITH ALOE VERA
K022444 · Wrp Asia Pacific Sdn. Bhd. · Sep 2002