Cleared Traditional

K982600 - PROFEEL SYNTHETIC COPOLYMER SURGICAL GL...

K982600 is an FDA 510(k) clearance for PROFEEL SYNTHETIC COPOLYMER SURGICAL GL..., manufactured by Wembley Rubber Products (M) Sdn Bhd. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K982600 · Wembley Rubber Products (M) Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
228d
Days
Class 1
Risk

K982600 is an FDA 510(k) clearance for the PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED). Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Wembley Rubber Products (M) Sdn Bhd (Selangor, Malaysia, MY). The FDA issued a Cleared decision on March 12, 1999 after a review of 228 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 Wembley Rubber Products (M) Sdn Bhd devices

FDA 510(k) Submission Details - K982600

510(k) Number K982600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1998
Decision Date March 12, 1999
Days to Decision 228 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
99d slower than avg
Panel avg: 129d · This submission: 228d
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 268
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K982600.
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
DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)
K984558 · Ansell Perry · Feb 1999
ELITE POWDER-FREE POLYURETHANE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)
K984559 · Ansell Perry · Feb 1999
SENSIFLEX POWDERFREE SURGEON'S GLOVE
K982957 · Terang Nusa Sdn Bhd · Jan 1999