Cleared Special

K983962 - ULTRAFREE TEXTURED STERILE LATEX POWDER...

K983962 is an FDA 510(k) clearance for ULTRAFREE TEXTURED STERILE LATEX POWDER..., manufactured by Cardinal Health-Medical Products and Services. The device is a Class 1 General Hospital device with product code KGO cleared through the Special 510(k) pathway after a 63-day FDA review.

K983962 · Cardinal Health-Medical Products and Services · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
63d
Days
Class 1
Risk

K983962 is an FDA 510(k) clearance for the ULTRAFREE TEXTURED STERILE LATEX POWDER-FREE SURGICAL GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Cardinal Health-Medical Products and Services (Mcgaw Park, US). The FDA issued a Cleared decision on January 8, 1999 after a review of 63 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cardinal Health-Medical Products and Services devices

FDA 510(k) Submission Details - K983962

510(k) Number K983962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1998
Decision Date January 08, 1999
Days to Decision 63 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 129d · This submission: 63d
Pathway characteristics
Modification to existing cleared device.

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 258
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K983962.
DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)
K984558 · Ansell Perry · Feb 1999
ELITE POWDER-FREE POLYURETHANE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)
K984559 · Ansell Perry · Feb 1999
SENSIFLEX POWDERFREE SURGEON'S GLOVE
K982957 · Terang Nusa Sdn Bhd · Jan 1999
ENCORE MARK IV POWDER FREE POLYMER COATED LATEX SURGICAL GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE)
K983489 · Ansell Perry · Dec 1998
DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES
K980929 · Ansell Perry · Jun 1998
SENSI-DERM LATEX SURGICAL GLOVES (POWDERED)
K980880 · Ansell Perry · May 1998