(62 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Dental Latex Examination Gloves are formulated using natural rubber latex and offered non-sterile.
This document describes the safety and effectiveness summary for Allegiance Dental Latex Examination Gloves with Protein Labeling Claim.
Here's an analysis of the provided text, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Primary Skin Irritation | No potential for irritation | Gloves do not display any potential for irritation. |
| Systemic Toxicity | No toxic reactions to acute application | Gloves do not elicit any toxic reactions to acute application. |
| Intracutaneous Reactivity | No reactivity | Gloves show no reactivity. |
| Hemocompatibility | No lysis | Gloves are hemocompatible exhibiting no lysis. |
| Guinea Pig Maximization | No potential for irritation | Gloves do not display any potential for irritation. |
| Ultimate Elongation & Tensile Strength | Meet or exceed requirements for rubber examination gloves per ASTM D3578-99 | Gloves meet or exceed requirements for rubber examination gloves per ASTM D3578-99. |
| Barrier Defects | Meet or exceed requirements per 21 CFR §800.20, AQL = 4.0 | Gloves meet or exceed requirements per 21 CFR §800.20, AQL = 4.0. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample sizes used for each of the listed tests (e.g., number of gloves tested for barrier defects, number of animals for skin irritation tests).
The data provenance is not explicitly stated as "country of origin." However, the manufacturer is "Allegiance Healthcare Sdn. Bhd. Plot 87. Kampung Jawa 11900 Bayan Lepas Penang, West Malaysia." The summary was prepared for the FDA in the USA. The tests themselves are scientific and generally accepted internationally. The text does not explicitly state if the studies were retrospective or prospective, but given the nature of product testing for regulatory submission, they would typically be prospective studies designed to assess product performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the text. The tests listed are for material properties and biological responses, rather than interpretation of diagnostic images or clinical scenarios that would typically require expert consensus as "ground truth." The "ground truth" for these tests are objective measurements or observable biological reactions.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods like "2+1" or "3+1" are typically used when multiple human readers are interpreting data or making diagnoses (e.g., in medical image analysis). For material and biological testing, the results are usually objectively measured or observed, often against established standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This information is not applicable. This document describes the safety and effectiveness of a physical medical device (examination gloves), not an artificial intelligence (AI) system or diagnostic tool that would involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This document is about a physical medical device.
7. The Type of Ground Truth Used
The ground truth used for these tests is based on:
- Objective measurements and scientific standards: For tests like Ultimate Elongation & Tensile Strength (against ASTM D3578-99) and Barrier Defects (against 21 CFR §800.20, AQL = 4.0).
- Observable biological responses: For tests like Primary Skin Irritation, Systemic Toxicity, Intracutaneous Reactivity, Hemocompatibility, and Guinea Pig Maximization, where the "ground truth" is the presence or absence of a specific adverse biological reaction as assessed according to established scientific protocols.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The concept of a "training set" is relevant to machine learning or AI development. For a physical device like examination gloves, the manufacturing process might involve process control parameters that are "trained" or optimized, but there isn't a "training set" of data in the AI sense. The text describes product testing to meet regulatory standards.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the reasons stated in point 8.
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9 2000 FEB
XIV. SUMMARY OF SAFETY AND EFFECTIVENESS
Allegiance
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DENTAL LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
Manufacturer: Allegiance Healthcare Sdn. Bhd. Plot 87. Kampung Jawa 11900 Bayan Lepas Penang, West Malaysia
Regulatory Affairs Contact: Erica Sethi Allegiance Healthcare Corporation 1500 Waukegan Road, Bldg. K McGaw Park, IL 60085
Telephone: (847) 785-3337
Date Summary Prepared: November 22, 1999
Product Trade Name: Dental Latex Examination Gloves With Protein Labeling Claim
Common Name: Examination Glove
Classification: Patient Examination Glove
Predicate Devices: Dental Latex Examination Gloves
Description: Dental Latex Examination Gloves are formulated using natural rubber latex and offered non-sterile.
Intended Use: These examination gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner. These Dental Latex Examination Gloves are intended specifically for Dentistry and will be worn during dental cleaning, filling and examination in non-sterile environments within hospitals and other healthcare facilities.
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Substantial Equivalence: The Dental Latex Examination Gloves With Protein Labeling Claim are substantially equivalent to Dental Latex Examination Gloves in that they provide the following characteristics:
- same intended use
- same sizes, configuration, packaging
- both made of natural rubber latex
- same tensile strength and thickness profiles
Summary of Testing:
| Test | Result |
|---|---|
| Primary Skin Irritation | Gloves do not display any potential for irritation. |
| Systemic Toxicity | Gloves do not elicit any toxic reactions to acute application. |
| Intracutaneous Reactivity | Gloves show no reactivity. |
| Hemocompatibility | Gloves are hemocompatible exhibiting no lysis. |
| Guinea Pig Maximization | Gloves do not display any potential for irritation. |
| Ultimate Elongation& Tensile Strength | Gloves meet or exceed requirements for rubber examination glovesper ASTM D3578-99. |
| Barrier Defects | Gloves meet or exceed requirements per 21 CFR$800.20, AQL = 4.0. |
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract symbol resembling an eagle or a person's profile. The symbol is composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
9 2000 FEB
Ms. Erica Sethi Manager, Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukeqan Road McGraw Park, Illinois 60085
K994162 Re : Powdered Dental Latex Powdered Examination Trade Name: Gloves, With Protein Content Labeling Claim (75 Micrograms Or Less) Requlatory Class: I Product Code: LYY Dated: January 24, 2000 Received: January 27, 2000
Dear Ms. Sethi:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in
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Page 2 - Ms. Sethi
the Federal Register. Please note: this response to your premarket notification submission does not affect any prematice nocerreder on under sections 531 through 542 of obligation you magno mars the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as fire is do " "I wour 510 k) premarket notification." The FDA described in your sie wir privalence of your device to a legally finding of bubbeaneral squresults in a classification for your marketed produces with your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in regaradiagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact che office of Compliance at (301) 594-4639. Also, please note the orrece or compiled, "Misbranding by reference to ene regulation one one (21 CFR 807.97). Other general premation on your responsibilities under the Act may be Information on your of Small Manufacturers Assistance obcarned from eno mumber (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the word "Allegiance" in a bold, italicized font. To the left of the word is a graphic of a cluster of dots arranged in a square pattern. The word is written in black, and the background is white.
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2460
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Applicant: Allegiance Healthcare Corporation
510(k) Number:
POWDERED
A Dental Latex Examination Gloves With Protein Labeling Claim Device Name: (75 micrograms or less)
Indications For Use: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
or
Over-The Counter Use /
Ohm S. Lim
(Division Sign-Off) Division of Dental, Infection C and General Hospital 5 1 O(k) Number .
6
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.