Cleared Traditional

K981947 - STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN)

K981947 is an FDA 510(k) clearance for STERILE POWDER FREE NITRILE SURGEONS GL..., manufactured by Boston Medical Corp.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K981947 · Boston Medical Corp. · General Hospital
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Mar 1999
Decision
273d
Days
Class 1
Risk

K981947 is an FDA 510(k) clearance for the STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN). Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Boston Medical Corp. (Annapolis Junction, US). The FDA issued a Cleared decision on March 3, 1999 after a review of 273 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 Boston Medical Corp. devices

FDA 510(k) Submission Details - K981947

510(k) Number K981947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1998
Decision Date March 03, 1999
Days to Decision 273 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 129d · This submission: 273d
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 K981947.
SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES
K983982 · Maxxim Medical · May 1999
ELASTYLON POWDER-FREE SURGICAL GLOVE
K984337 · Eci Medical Technologies, Inc. · Apr 1999
PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED)
K982600 · Wembley Rubber Products (M) Sdn Bhd · Mar 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