(62 days)
Not Found
Not Found
No
The device is a simple examination glove with no mention of AI/ML capabilities or related technologies.
No
The device is a glove intended to prevent contamination, not to treat or diagnose a disease or condition.
No
Explanation: The device is a patient examination glove, described as preventing contamination between patient and examiner. Its "Intended Use" explicitly states it's for medical purposes worn on the hand or finger. The "Summary of Performance Studies" focuses on material safety (irritation, toxicity, hemocompatibility) and physical properties (elongation, tensile strength, barrier defects), which are not characteristic of a diagnostic device. There is no mention of the device being used to identify or determine the presence of a disease, condition, or health status.
No
The device description clearly states it is a physical product (gloves) made of natural rubber latex, not software.
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 hand or finger to prevent contamination. This is a physical barrier device used during patient examination.
- Device Description: The description confirms it's a glove made of natural rubber latex.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a patient's health status. IVDs typically involve analyzing biological samples like blood, urine, or tissue.
- Performance Studies: The performance studies focus on the physical properties of the glove (tensile strength, elongation, barrier defects) and biocompatibility (skin irritation, toxicity, hemocompatibility). These are relevant to a physical barrier device, not an IVD.
Therefore, this device falls under the category of a medical device used for physical protection and barrier function, not an in vitro diagnostic.
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 (comma separated list FDA assigned to the subject device)
LYY
Device Description
Dental 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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. |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Dental Latex Examination Gloves
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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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 gloves |
| per 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
Page 1 of 1
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.
(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 /
Ohm S. Lim
(Division Sign-Off) Division of Dental, Infection C and General Hospital 5 1 O(k) Number .
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