Cleared Traditional

K831564 - ORTHOPEDIC SURGICAL GLOVE

K831564 is the FDA 510(k) clearance for ORTHOPEDIC SURGICAL GLOVE by Ansell, Inc.. It is a Class 1 General Hospital device (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.

View all Ansell, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 129d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Devices cleared under the same product code (FMC) and FDA review panel - the closest regulatory comparables to K831564.
COMFIT, PATIENT EXAMINATION GLOVES
K903746 · Wembley Rubber Products (M) Sdn Bhd · Sep 1990
FINGER COTS
K821028 · Abco Dealers, Inc. · Apr 1982
SUTURE WOUND TRAY MILFORD WHITTINSVILLE
K802386 · American Medical Disposable, Inc. · Nov 1980
CONPHAR EXAM. GLOVES, POLYETHYLENE
K791805 · Conphar, Inc. · Oct 1979
CATHETEO CARE TRAY #0242
K771673 · Concord Laboratories, Inc. · Sep 1977
LACERATION KIT
K770479 · American Hospital Supply Corp. · Apr 1977