Cleared Traditional

K903534 - SURGEON'S (SURGICAL) GLOVES

K903534 is an FDA 510(k) clearance for SURGEON'S (SURGICAL) GLOVES, manufactured by Straitscom. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K903534 · Straitscom · General Hospital
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Aug 1990
Decision
11d
Days
Class 1
Risk

K903534 is an FDA 510(k) clearance for the SURGEON'S (SURGICAL) GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Straitscom (Clarksville, US). The FDA issued a Cleared decision on August 17, 1990 after a review of 11 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 Straitscom devices

FDA 510(k) Submission Details - K903534

510(k) Number K903534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1990
Decision Date August 17, 1990
Days to Decision 11 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 129d · This submission: 11d
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 375
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K903534.
EUDERMIC SURGICAL GLOVES
K911245 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1991
TRIFLEX(R) ORTH STERILE SURGEON'S GLOVES, MODIFIED
K903987 · Baxter Healthcare Corp · Oct 1990
COMFIT SURGEON'S GLOVES
K903446 · Wembley Rubber Products (M) Sdn Bhd · Oct 1990
TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE
K902380 · Baxter Healthcare Corp · Jun 1990
TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE
K897192 · Baxter Healthcare Corp · Feb 1990
POWDER-FREE/HYPO-ALLERGENIC STERILE SURGEON GLOVES
K895669 · Safeskin Corp. · Nov 1989