Cleared Traditional

K831564 - ORTHOPEDIC SURGICAL GLOVE

K831564 is an FDA 510(k) clearance for ORTHOPEDIC SURGICAL GLOVE, manufactured by Ansell, Inc.. The device is a Class 1 General Hospital device with product code FMC cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K831564 · Ansell, Inc. · General Hospital
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Jul 1983
Decision
57d
Days
Class 1
Risk

K831564 is an FDA 510(k) clearance for the ORTHOPEDIC SURGICAL GLOVE. Classified as Patient Examination Glove (product code FMC), Class I - General Controls.

Submitted by Ansell, Inc. (Dothan, US). The FDA issued a Cleared decision on July 12, 1983 after a review of 57 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - 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 - K831564

510(k) Number K831564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1983
Decision Date July 12, 1983
Days to Decision 57 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
72d faster than avg
Panel avg: 129d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

FMC Device Classification - Class 1, General Controls

Product Code FMC Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
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 - FMC Patient Examination Glove

All 33
Devices cleared under the same product code (FMC) and FDA review panel - the closest regulatory comparables to K831564.
TPN/CVP DRESSING CHANGE KIT
K840620 · Marwood Medical, Inc. · May 1984
P.T.I. DRESSING CHANGE TRAYS
K833758 · Packaging Technologies, Inc. · Jan 1984
CMS 2000 SERIES TPN KITS
K831964 · Currie Medical Specialties, Inc. · Aug 1983
STERILE PATIENT EXAM. GLOVES
K821043 · Phoenix Glove Co. · May 1982
FINGER COTS
K821028 · Abco Dealers, Inc. · Apr 1982
SUTURE WOUND TRAY MILFORD WHITTINSVILLE
K802386 · American Medical Disposable, Inc. · Nov 1980
K831564 · ORTHOPEDIC SURGICAL GLOVE
Download PDF Ansell, Inc.