(6 days)
LYY
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No.
The device prevents contamination between patient and examiner by acting as a barrier, rather than directly treating a disease, injury, or condition.
No
Explanation: The device, a patient examination glove, is used to prevent contamination between patient and examiner. Its intended use and description do not mention any diagnostic function, such as identifying or detecting diseases or conditions. The performance studies focus on physical properties and irritation potential, not diagnostic accuracy.
No
The device is a physical examination glove made of latex, not a software application.
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 device is a "patient examination glove...worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection during physical examination, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the material (natural rubber latex) and form (non-sterile, powder-free gloves). This aligns with a physical barrier device.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information
- Using reagents or assays
The information provided strongly indicates that this device is a Class I medical device (or potentially Class II depending on specific regulations and claims) intended for barrier protection during patient examinations.
N/A
Intended Use / Indications for 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.
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.
Product codes
LYY
Device Description
Dental Powder-Free Latex Examination Gloves are formulated using natural rubber latex and offered non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or fingers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner, hospitals and other healthcare facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
| Test | Result |
|---|---|
| Primary Skin Irritation | Gloves do not display any potential for irritation. |
| Guinea Pig Maximization | Gloves do not display any potential for irritation. |
| Ultimate Elongation | |
| & Tensile Strength | Gloves meet or exceed requirements for rubber examination |
| gloves per ASTM D3578-01. | |
| Barrier Defects | Gloves meet or exceed requirements per 21 CFR |
| §800.20 and ASTM D 3578-01. |
Key Metrics
Not Found
Predicate Device(s)
Dental Latex Powdered Examination Gloves
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
XIII. SUMMARY OF SAFETY AND EFFECTIVENESS
Allegiance
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
Manufacturer: Allegiance Healthcare Corporation 1500 Waukegan road McGaw Park, IL 60085
Regulatory Affairs Contact: Erica Sethi Allegiance Healthcare Corporation 1500 Waukegan Road, Bldg. K McGaw Park, IL 60085
Telephone: (847) 785-3337
Date Summary Prepared: 11/20/02
Product Trade Name: Undetermined
Common Name: Examination Glove
Classification: Patient Examination Glove
Predicate Devices: Dental Latex Powdered Examination Gloves
Description: Dental Powder-Free 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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Page 2
Substantial Equivalence: The Dental Powder-Free Latex Examination Gloves With Protein Labeling Claim are substantially equivalent to Dental Latex Powdered 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
- both hand specific non-sterile examination gloves
Summary of Testing:
| Test | Result |
|---|---|
| Primary Skin Irritation | Gloves do not display any potential for irritation. |
| Guinea Pig Maximization | Gloves do not display any potential for irritation. |
| Ultimate Elongation | |
| & Tensile Strength | Gloves meet or exceed requirements for rubber examination |
| gloves per ASTM D3578-01. | |
| Barrier Defects | Gloves meet or exceed requirements per 21 CFR |
| §800.20 and ASTM D 3578-01. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle image.
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
Ms. Erica Sethi Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukegan Road, Building K McGraw Park, Illinois 60085
Re: K024102
Trade/Device Name: Dental Powder-Free Latex Examination Gloves with Protein Labeling Claim Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: November 20, 2002 Received: December 12, 2002
Dear Ms. Sethi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Sethi
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Larson
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Allegiance
Allegiance Healthcare Corporation
1500 Waukegan Road
McGaw Park, Illinois 60085-6787
847.473.1500
FAX: 847.785.2460
Page 1 of 1
Applicant:
Allegiance Healthcare Corporation
510(k) Number:
Device Name:
Dental Powder-Free Latex Examination Gloves With Protein Labeling Claim
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
or
Over-The Counter Use
Clins S. Com
(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number K024102