Cleared Traditional

K903987 - TRIFLEX(R) ORTH STERILE SURGEON'S GLOVES, MODIFIED

K903987 is an FDA 510(k) clearance for TRIFLEX ORTH STERILE SURGEON'S GLOVES, manufactured by Baxter Healthcare Corp. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K903987 · Baxter Healthcare Corp · General Hospital
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Oct 1990
Decision
49d
Days
Class 1
Risk

K903987 is an FDA 510(k) clearance for the TRIFLEX(R) ORTH STERILE SURGEON'S GLOVES, MODIFIED. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on October 11, 1990 after a review of 49 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.

FDA 510(k) Submission Details - K903987

510(k) Number K903987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1990
Decision Date October 11, 1990
Days to Decision 49 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 129d · This submission: 49d
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 559
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K903987.
KLEARTEX LATEX SURGEONS GLOVES
K904361 · Kleartex Sdn Bhd · Dec 1990
RUBBER LATEX SURGICAL GLOVES, STERILE
K905161 · Rfb Latex Pvt. , Ltd. · Nov 1990
STERILE SURGEONS GLOVES (ULTRA-TOUCH-LATEX)
K904320 · R.K.F. Laboratories, Inc. · Nov 1990
COMFIT SURGEON'S GLOVES
K903446 · Wembley Rubber Products (M) Sdn Bhd · Oct 1990
LATEX SURGICAL GLOVES (YUETONG ENTERPRISE CO. LTD)
K902714 · Quinhuangda Yuetong Ent. Co., Ltd. · Sep 1990
SANOFLEX-STERILE LATEX SURGICAL GLOVES
K903513 · Lowenkamp Intl., Inc. · Sep 1990
K903987 · TRIFLEX(R) ORTH STERILE SURGEON'S GLOVES, MODIFIED
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