Cleared Traditional

K895603 - S.S.T. SURGICAL THIMBLE

K895603 is an FDA 510(k) clearance for S.S.T. SURGICAL THIMBLE, manufactured by Healthcare Technologies Resources, Inc.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K895603 · Healthcare Technologies Resources, Inc. · General Hospital
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Oct 1989
Decision
18d
Days
Class 1
Risk

K895603 is an FDA 510(k) clearance for the S.S.T. SURGICAL THIMBLE. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Healthcare Technologies Resources, Inc. (Sparks, US). The FDA issued a Cleared decision on October 6, 1989 after a review of 18 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 - K895603

510(k) Number K895603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1989
Decision Date October 06, 1989
Days to Decision 18 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
111d faster than avg
Panel avg: 129d · This submission: 18d
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 490
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K895603.
STERILE SURGEONS GLOVES
K894256 · Chung Shiang Rubber Industrial Co. · Oct 1989
SURGICAL GLOVES
K894010 · Green Cross Medical Supplies Corp. · Oct 1989
RUBBER LATEX SURGICAL GLOVES, STERILE
K895448 · Dah Lee Rubber Industries (Thai) , Ltd. · Oct 1989
MEDPRIDE LATEX SURGEONS GLOVES
K895027 · Medpride · Sep 1989
INAMED PRO-TEC SILICONE SURGICAL GLOVES
K894073 · Inamed Development Co. · Sep 1989
STERILE LATEX SURGICAL GLOVES
K893899 · Life Force Laboratories, Inc. · Sep 1989
K895603 · S.S.T. SURGICAL THIMBLE
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