Cleared Traditional

K992679 - SURGEON POWDER-FREE GLOVES

K992679 is an FDA 510(k) clearance for SURGEON POWDER-FREE GLOVES, manufactured by Wear Safe Malaysia Sdn. Bhd.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K992679 · Wear Safe Malaysia Sdn. Bhd. · General Hospital
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Oct 1999
Decision
72d
Days
Class 1
Risk

K992679 is an FDA 510(k) clearance for the SURGEON POWDER-FREE GLOVES, LATEX, STERILE. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Wear Safe Malaysia Sdn. Bhd. (Port Klang, Selangor, D.E., MY). The FDA issued a Cleared decision on October 21, 1999 after a review of 72 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 Wear Safe Malaysia Sdn. Bhd. devices

FDA 510(k) Submission Details - K992679

510(k) Number K992679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1999
Decision Date October 21, 1999
Days to Decision 72 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 129d · This submission: 72d
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 272
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K992679.
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
SURGEONS GLOVE, BROWN LATEX POLYMER COATED, POWDER FREE WITH PROTEIN LABEL CLAIM
K992953 · Ansell Perry · Oct 1999
ULTRADERM STERILE LATEX POWDERED SURGICAL SLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K991205 · Allegiance Healthcare Corp. · Oct 1999
COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K992171 · Allegiance Healthcare Corp. · Sep 1999
LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDERED)
K991949 · La Glove (M) Sdn. Bhd. · Aug 1999