Cleared Abbreviated

K983982 - SENSICARE SYNTHETIC POWDER FREE SURGICA...

K983982 is an FDA 510(k) clearance for SENSICARE SYNTHETIC POWDER FREE SURGICA..., manufactured by Maxxim Medical. The device is a Class 1 General Hospital device with product code KGO cleared through the Abbreviated 510(k) pathway after a 176-day FDA review.

K983982 · Maxxim Medical · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
176d
Days
Class 1
Risk

K983982 is an FDA 510(k) clearance for the SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Maxxim Medical (Clearwater, US). The FDA issued a Cleared decision on May 4, 1999 after a review of 176 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Maxxim Medical devices

FDA 510(k) Submission Details - K983982

510(k) Number K983982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1998
Decision Date May 04, 1999
Days to Decision 176 days
Submission Type Abbreviated
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
47d slower than avg
Panel avg: 129d · This submission: 176d
Pathway characteristics
Standards-based clearance path.

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 241
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K983982.
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
PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED)
K982600 · Wembley Rubber Products (M) Sdn Bhd · Mar 1999
SENSIFLEX POWDERFREE SURGEON'S GLOVE
K982957 · Terang Nusa Sdn Bhd · Jan 1999
ULTRALON POWDER FREE LATEX SURGICAL GLOVE
K973699 · Johnson & Johnson Medical, Inc. · Dec 1997