Cleared Traditional

K913766 - ANSELL NO POWDER AMBI PATIENT EXAMINATION GLOVES

K913766 is an FDA 510(k) clearance for ANSELL NO POWDER AMBI PATIENT EXAMINATI..., manufactured by Ansell, Inc.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 567-day FDA review.

K913766 · Ansell, Inc. · General Hospital
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Mar 1993
Decision
567d
Days
Class 1
Risk

K913766 is an FDA 510(k) clearance for the ANSELL NO POWDER AMBI PATIENT EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Ansell, Inc. (Thailand, TH). The FDA issued a Cleared decision on March 11, 1993 after a review of 567 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

FDA 510(k) Submission Details - K913766

510(k) Number K913766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1991
Decision Date March 11, 1993
Days to Decision 567 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
438d slower than avg
Panel avg: 129d · This submission: 567d
Pathway characteristics
Predicate-based equivalence.

LYY Device Classification - Class 1, General Controls

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes 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 - LYY Latex Patient Examination Glove

All 1953
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K913766.
DERMATOUCH PLUS HYPOALLERGENIC EXAMINATION GLOVES
K925358 · Colonial Surgical Supply, Inc. · Apr 1993
DOCTOR'S CHOICE LATEX EXAMINATION GLOVES
K924265 · Chesire Laboratories · Mar 1993
SAVACARE LATEX EXAMINATION GLOVES
K924233 · Preventive Care, Inc. · Mar 1993
PATIENT EXAMINATION GLOVES
K915607 · Seal Polymer Industries Bhd. · Mar 1993
STERLING LATEX EXAM GLOVE, HYPO-ALLERGENIC
K924959 · Perlink USA, Inc. · Mar 1993
HYGIENEX EXAMINATION GLOVES
K922903 · Hygienex Corp. · Feb 1993
K913766 · ANSELL NO POWDER AMBI PATIENT EXAMINATION GLOVES
Download PDF Ansell, Inc.