(97 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of examination gloves, with no mention of AI or ML.
No.
The device's intended use is to prevent contamination and protect the wearer from chemotherapy drugs, not to treat or cure a disease or condition.
No
Explanation: The provided text describes a patient examination glove, which is a barrier device for protection, not a device used to diagnose medical conditions or diseases.
No
The device is a physical medical device (examination gloves) and does not involve any software component.
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 and protect against chemotherapy drugs. This is a barrier device for external use.
- Device Description: The description focuses on the material (nitrile), form (powder-free), and coating.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. The testing described (skin irritation, tensile strength, barrier defects, chemotherapy testing) relates to the physical properties and protective capabilities of the glove, not to the analysis of biological samples.
IVD devices are specifically designed to perform tests on samples taken from the body to gain information about a person's health. This glove's function is to act as a physical barrier between the examiner and the patient/substances.
N/A
Intended Use / 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. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs.
Product codes
LZC
Device Description
Nitrile Powder-Free Examination Gloves with coating are formulated using nitrile and offered powder-free.
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
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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)
| Test | Result |
|---|---|
| Primary Skin Irritation | Gloves show no irritation. |
| Guinea Pig Maximization | Gloves do not display any potential for irritation. |
| Tensile Strength | Gloves meet or exceed requirements per ASTM D6319-00a3. |
| Barrier Defects | Gloves meet or exceed requirements per 21 CFR§800.20 |
| and ASTM D6319-00a63. | |
| Chemotherapy testing | Tested for chemotherapy drugs using ASTM F739-99a |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Nitrile Powder-Free Examination Gloves, Cardinal Health,
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.
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NOV 1 3 2003
Image /page/0/Picture/2 description: The image shows the Cardinal Health logo. The logo consists of the words "CardinalHealth" in a stylized font. Above the text, there is a graphic element that resembles a series of intersecting lines or strokes, possibly representing a stylized bird or abstract design.
XIII. SUMMARY OF SAFETY AND EFFECTIVENESS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS LOT OF STOP TH COATING, BLUE NITRILE POWDER-FREE EXAMINA TION GLC WIFF for
Applicant/Sponsor: Cardinal Health 1500 Waukegan Road McGaw Park, IL 60085
Regulatory Affairs Contact: Erica Sethi Cardinal Health 1500 Waukegan Road, Bldg. WM McGaw Park, IL 60085
Telephone: (847) 785-3337
Date Summary Prepared: 7/25/03
Product Trade Name: Undetermined
Common Name: Examination Glove
Classification: Patient Examination Glove
Predicate Devices: Nitrile Powder-Free Examination Gloves, Cardinal Health,
Description: Nitrile Powder-Free Examination Gloves with coating are formulated using nitrile and offered powder-free.
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. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs.
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Substantial Equivalence: Nitrile Powder-Free Examination Gloves with Coating are substantially equivalent to Cardinal Health's Nitrile Powder-Free Examination Gloves in that they provide the following characteristics:
- same intended use
- same sizes
- both made of nitrile
- both offered beaded and powder-free
- both worn to protect the wearer against exposure to chemotherapy drugs
Summary of Testing:
| Test | Result |
|---|---|
| Primary Skin Irritation | Gloves show no irritation. |
| Guinea Pig Maximization | Gloves do not display any potential for irritation. |
| Tensile Strength | Gloves meet or exceed requirements per ASTM D6319-00a3. |
| Barrier Defects | Gloves meet or exceed requirements per 21 CFR§800.20 |
| and ASTM D6319-00a63. | |
| Chemotherapy testing | Tested for chemotherapy drugs using ASTM F739-99a |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services.
Public Health Service
NOV 1 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cardinal Health C/O Ms. Erica Sethi Manager, Regulatory Affairs Medial Product and Services 1500 Waukegan Road Bldg WM Mcgaw Park, Illinois 60085
Re: K032444
Trade/Device Name: Nitrile Powdered- Free Examination Glove with Lotion Coating And use for Chemotherapy Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZC Dated: October 23, 2003 Received: October 30, 2003
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 your 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
QurLs
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental 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 logo for Cardinal Health. The logo consists of three curved lines above the company name. The company name is written in a sans-serif font, with the word "Cardinal" in a smaller font size than the word "Health."
1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2460
Susanna F. Basuld
Anesthesiology, General Hospital, on Control, Dental Devices
510(k) Number: K032444
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Applicant:
Cardinal Health