Cleared Traditional

K000896 - POWDERFREE LATEX SURGEON'S GLOVES WITH PROTIEN LABELING CLAIM (50 MOCROGRAMS OR LESS

K000896 is an FDA 510(k) clearance for POWDERFREE LATEX SURGEON'S GLOVES WITH ..., manufactured by Fitco Dipped Products Pvt., Ltd.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K000896 · Fitco Dipped Products Pvt., Ltd. · General Hospital
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May 2000
Decision
44d
Days
Class 1
Risk

K000896 is an FDA 510(k) clearance for the POWDERFREE LATEX SURGEON'S GLOVES WITH PROTIEN LABELING CLAIM (50 MOCROGRAMS .... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Fitco Dipped Products Pvt., Ltd. (Kerala, IN). The FDA issued a Cleared decision on May 3, 2000 after a review of 44 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 Fitco Dipped Products Pvt., Ltd. devices

FDA 510(k) Submission Details - K000896

510(k) Number K000896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2000
Decision Date May 03, 2000
Days to Decision 44 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
85d faster than avg
Panel avg: 129d · This submission: 44d
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 352
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K000896.
NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN
K000178 · Terang Nusa Sdn Bhd · May 2000
NUZONE NITRILE SURGICAL GLOVES POWDER FREE
K000179 · Terang Nusa Sdn Bhd · May 2000
ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K001239 · Ansell Perry · May 2000
HEALTH-PLUS, SANITEX, RELIANCE STERILE POWDER-FREE NITRILE SURGICAL GLOVES
K993756 · Pamitex Industries Sdn Bhd · Apr 2000
PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILE
K000971 · Wrp Asia Pacific Sdn. Bhd. · Apr 2000
HEALTH-PLUS, SANITEX, RELIANCE POWEDER-FREE STERILE LATEX SURGICAL GLOVES
K993201 · Pamitex Industries Sdn Bhd · Mar 2000