Cleared Traditional

K984395 - SURGEON'S GLOVES

K984395 is an FDA 510(k) clearance for SURGEON'S GLOVES, manufactured by Sri Anusham Rubber Industries Pvt., Ltd.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K984395 · Sri Anusham Rubber Industries Pvt., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
164d
Days
Class 1
Risk

K984395 is an FDA 510(k) clearance for the SURGEON'S GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Sri Anusham Rubber Industries Pvt., Ltd. (Vadasery, Nagercoil, Tn, IN). The FDA issued a Cleared decision on May 21, 1999 after a review of 164 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 Sri Anusham Rubber Industries Pvt., Ltd. devices

FDA 510(k) Submission Details - K984395

510(k) Number K984395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1998
Decision Date May 21, 1999
Days to Decision 164 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
35d slower than avg
Panel avg: 129d · This submission: 164d
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 K984395.
NITRILON CORRECT-TOUCH
K984512 · Ct Intl. · 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
POWDER-FREE LATEX SURGEON'S GLOVE SAFESKIN PFS PLUS CONTAINS 50MLGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
K991317 · Safeskin Corp. · May 1999
SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES
K983982 · Maxxim Medical · May 1999
ELASTYLON POWDER-FREE SURGICAL GLOVE
K984337 · Eci Medical Technologies, Inc. · Apr 1999