Cleared Traditional

K001274 - LATEX SURGEON SURGEON'S GLOVES POWDER-F...

K001274 is an FDA 510(k) clearance for LATEX SURGEON SURGEON'S GLOVES POWDER-F..., manufactured by Pt. Maja Agung Latexindo. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K001274 · Pt. Maja Agung Latexindo · General Hospital
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Jun 2000
Decision
64d
Days
Class 1
Risk

K001274 is an FDA 510(k) clearance for the LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING CLAI.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Pt. Maja Agung Latexindo (City Of Industry, US). The FDA issued a Cleared decision on June 23, 2000 after a review of 64 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 Pt. Maja Agung Latexindo devices

FDA 510(k) Submission Details - K001274

510(k) Number K001274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2000
Decision Date June 23, 2000
Days to Decision 64 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 129d · This submission: 64d
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 242
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K001274.
STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES
K002933 · Maxxim Medical · Oct 2000
POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
K001959 · Hartalega Sdn Bhd · Jul 2000
COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS0
K001924 · Allegiance Healthcare Corp. · Jul 2000
NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN
K000178 · Terang Nusa Sdn Bhd · May 2000
NUZONE NITRILE SURGICAL GLOVES POWDER FREE
K000179 · Terang Nusa Sdn Bhd · May 2000
PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILE
K000971 · Wrp Asia Pacific Sdn. Bhd. · Apr 2000