K Number
K964474
Device Name
ULTRAFREE STERILE LATEX POWDER-FREE SURGICAL GLOVES
Date Cleared
1997-03-11

(124 days)

Product Code
Regulation Number
878.4460
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ultrafree Sterile Latex Powder-Free Surgical Gloves are intended for use in sterile environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive surgical procedures and non-invasive medical procedures requiring sterility. They are intended to be worn by operating room personnel to protect a surgical wound from contamination
Device Description
The Ultrafree Surgical gloves are formulated using natural rubber latex and offered sterile.
More Information

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No
The document describes sterile surgical gloves and does not mention any AI or ML components or functionalities.

No
This device is a surgical glove, intended to protect from contamination, not to treat or diagnose a disease or condition.

No

Explanation: The device is described as surgical gloves intended to protect a surgical wound from contamination and for use during procedures. It does not mention any diagnostic function such as detecting, identifying, or monitoring a disease or condition.

No

The device is a physical product (surgical gloves) and the description focuses on material properties and performance testing related to those physical properties. There is no mention of software components.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the gloves are for use in sterile environments during surgical and non-invasive medical procedures to protect a surgical wound from contamination and to be worn by operating room personnel. This is a barrier function, not a diagnostic one.
  • Device Description: The description confirms they are surgical gloves made of natural rubber latex.
  • Lack of Diagnostic Elements: There is no mention of the device being used to examine specimens from the human body (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
  • Performance Studies: The performance studies focus on safety (skin irritation, toxicity, hemocompatibility) and physical properties (elongation, tensile strength, barrier defects, powder level). These are relevant to a medical device used as a barrier, not an IVD.

IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. Surgical gloves, while a medical device, do not fit this definition.

N/A

Intended Use / Indications for Use

Ultrafree Sterile Latex Powder-Free Surgical Gloves are intended for use in sterile environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive surgical procedures and non-invasive medical procedures requiring sterility. They are intended to be worn by operating room personnel to protect a surgical wound from contamination

Product codes

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Device Description

The Ultrafree Surgical gloves are formulated using natural rubber latex and offered sterile.

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

operating room personnel / hospitals and other healthcare facilities

Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies

TestResult
Primary Skin IrritationGlove does not display any potential for irritation.
Systemic ToxicityGlove does not elicit any toxic reactions to acute application.
Intracutaneous ReactivityNo reactivity was observed.
HemocompatibilityGloves are hemocompatible exhibiting no lysis.
Guinea Pig MaximizationGlove does not display any potential for irritation.
Ultimate Elongation & Tensile StrengthGlove meets or exceeds requirements for rubber surgical gloves per ASTM D3577-91.
Barrier DefectsGlove meets or exceeds requirements per 21 CFR §800.20, AQL = 2.5.
Data/Test MethodGlove meets powder level requirements for "Powder Free" designation using the vacuum filtration method plus a negative iodine test. Results generated values below the 2 mg/glove cornstarch level including negative iodine test.

Key Metrics

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Predicate Device(s)

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Reference Device(s)

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Predetermined Change Control Plan (PCCP) - All Relevant Information

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§ 878.4460 Non-powdered surgeon's glove.

(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).

0

MAR 1 1 1997

K964474

XIV. SUMMARY OF SAFETY AND EFFECTIVENESS

Image /page/0/Picture/3 description: The image shows the word "Allegiance" in a bold, stylized font. The word is written in black, and there is a cluster of small dots above and to the left of the word. The dots appear to be arranged in a somewhat random pattern, creating a visual element that complements the text.

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ULTRAFREE STERILE LATEX POWDER-FREE SURGICAL GLOVES

| Manufacturer: | Allegiance Healthcare Sdn. Bhd.
Plot 87 Kampung Jawa
11900 Bayan Lepas
Penang, West Malaysia |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Maryalice Smith
Allegiance Healthcare Corporation
1500 Waukegan Road, Bldg. K
McGaw Park, IL 60085 |
| Telephone: | (847) 785-3322 |
| Date Summary Prepared: | February, 1997 |
| Product Trade Name: | Ultrafree Sterile Latex Powder-Free Surgical Gloves |
| Common Name: | Surgical Glove |
| Classification: | Glove, Surgical |
| Predicate Devices: | Triflex° Sterile Latex Powder-Free Surgical Gloves |
| Description: | The Ultrafree Surgical gloves are formulated using
natural rubber latex and offered sterile. |
| Intended Use: | Ultrafree Sterile Latex Powder-Free Surgical Gloves are
intended for use in sterile environments within hospitals and
other healthcare facilities. The gloves are appropriate for
use during invasive surgical procedures and non-invasive medical
procedures requiring sterility. They are intended to be worn by
operating room personnel to protect a surgical wound from
contamination |

1

Substantial Equivalence:

The Ultrafree Sterile Latex Powder-Free Surgical Gloves are substantially equivalent to Triflex® Sterile Latex Powder-Free Surgical Gloves in that they provide the following characteristics:

  • intended use
  • size, configuration, packaging
  • made of natural rubber latex
  • tensile strength and thickness profiles

Summary of Testing:

TestResult
Primary Skin IrritationGlove does not display
any potential for irritation.
Systemic ToxicityGlove does not elicit any
toxic reactions to acute
application.
Intracutaneous ReactivityNo reactivity was observed.
HemocompatibilityGloves are hemocompatible
exhibiting no lysis.
Guinea Pig MaximizationGlove does not display any
potential for irritation.
Ultimate Elongation
& Tensile StrengthGlove meets or exceeds
requirements for rubber
surgical gloves per
ASTM D3577-91.
Barrier DefectsGlove meets or exceeds
requirements per 21 CFR
§800.20, AQL = 2.5.
Data/Test MethodGlove meets powder level
requirements for "Powder Free"
designation using the vacuum filtration
method plus a negative iodine test.
Results generated values below the
2 mg/glove cornstarch level including
negative iodine test.