Cleared Traditional Expedited

K984512 - NITRILON CORRECT-TOUCH

K984512 is an FDA 510(k) clearance for NITRILON CORRECT-TOUCH, manufactured by Ct Intl.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K984512 · Ct Intl. · General Hospital
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Jul 1999
Decision
206d
Days
Class 1
Risk

K984512 is an FDA 510(k) clearance for the NITRILON CORRECT-TOUCH. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Ct Intl. (San Luis Obispo, US). The FDA issued a Cleared decision on July 12, 1999 after a review of 206 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 Ct Intl. devices

FDA 510(k) Submission Details - K984512

510(k) Number K984512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1998
Decision Date July 12, 1999
Days to Decision 206 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
77d slower than avg
Panel avg: 129d · This submission: 206d
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 297
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K984512.
LAGLOVE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K992019 · La Glove (M) Sdn. Bhd. · Aug 1999
LAGLOVE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS)
K992018 · La Glove (M) Sdn. Bhd. · Jul 1999
ULTRAFREE THICK STERILE LATEX POWDER-FREE SURGICAL GLOVES
K991992 · Allegiance Healthcare Corp. · Jul 1999
BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED)
K991940 · Brightway Holdings Sdn. Bhd. · Jul 1999
BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDER-FREE)
K991939 · Brightway Holdings Sdn. Bhd. · Jul 1999
SURGEON'S GLOVES
K984395 · Sri Anusham Rubber Industries Pvt., Ltd. · May 1999