Cleared Special

K003895 - X-TENDA CUFF POWDER FREE LATEX SURGICAL...

K003895 is an FDA 510(k) clearance for X-TENDA CUFF POWDER FREE LATEX SURGICAL..., manufactured by Ansell Perry. The device is a Class 1 General Hospital device with product code KGO cleared through the Special 510(k) pathway after a 30-day FDA review.

K003895 · Ansell Perry · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
30d
Days
Class 1
Risk

K003895 is an FDA 510(k) clearance for the X-TENDA CUFF POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING .... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Ansell Perry (Massillon, US). The FDA issued a Cleared decision on January 17, 2001 after a review of 30 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 Ansell Perry devices

FDA 510(k) Submission Details - K003895

510(k) Number K003895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2000
Decision Date January 17, 2001
Days to Decision 30 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 129d · This submission: 30d
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 260
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K003895.
ULTRAFREE MAX STERILE LATEX POWEDER-FREE SURGICAL GLOVES WITH PROTEIN LABELING CLAIM, 50 PER GRAM OR LESS OF TOTAL WATER
K010862 · Allegiance Healthcare Corp. · Jun 2001
MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING CLAIM (50 MICRGRAMS OR LESS)
K010438 · Terang Nusa Sdn Bhd · May 2001
MAXITEX DUPLEX STERILE LATEX POWDERED SURGEON GLOVES WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS)
K010439 · Terang Nusa Sdn Bhd · May 2001
POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
K002593 · Hartalega Sdn Bhd · Nov 2000
PROFEEL POWDER FREE POLYMER COATED NEOPRENE SURGICAL GLOVES STERILE
K003019 · Wrp Asia Pacific Sdn. Bhd. · Nov 2000
STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES
K002933 · Maxxim Medical · Oct 2000