Cleared Traditional

K993450 - LATEX SURGICAL GLOVES, PRE-POWDERED

K993450 is an FDA 510(k) clearance for LATEX SURGICAL GLOVES, 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 78-day FDA review.

K993450 · Fitco Dipped Products Pvt., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
78d
Days
Class 1
Risk

K993450 is an FDA 510(k) clearance for the LATEX SURGICAL GLOVES, PRE-POWDERED. 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 December 29, 1999 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 Fitco Dipped Products Pvt., Ltd. devices

FDA 510(k) Submission Details - K993450

510(k) Number K993450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1999
Decision Date December 29, 1999
Days to Decision 78 days
Submission Type Traditional
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
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 351
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K993450.
ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K000295 · Ansell Perry · Feb 2000
THE ORIGINAL PERRY, STYLE 42 WHITE LATEX POWDERED SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (60 MICROGRAMS OR
K993857 · Ansell Perry · Jan 2000
SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES
K994081 · Safeskin Corp. · Jan 2000
POWDER FREE LATEX STERILE SURGICAL GLOVES
K993562 · Tg Medical Sdn. Bhd. · Dec 1999
DERMAGRIP POWDER-FREE LATEX SURGICAL GLOVE, STERILE (PROTEIN CONTENT LABELING 50 MICROGRAMS OR LESS)
K993214 · Wrp Specialty Products Sdn. Bhd. · Dec 1999
DERMAGRIP POWDERED LATEX SURGICAL GLOVE, STERILE
K993215 · Wrp Specialty Products Sdn. Bhd. · Dec 1999