(160 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of examination gloves, with no mention of AI or ML.
No
The device is described as an "examination glove," which is used to prevent contamination between patient and examiner. This function is protective rather than therapeutic (i.e., it does not aim to cure, treat, or prevent disease in the patient).
No
The device is described as a "patient examination glove," which is a barrier device used to prevent contamination, not to diagnose a condition.
No
The device is a physical examination glove, which is a hardware medical device, not software. The description focuses on material properties and physical characteristics.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used during physical examination, not a device used to examine specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The description focuses on the physical characteristics of the glove (material, coating, manufacturing process), which are relevant to its function as a barrier. There is no mention of reagents, assays, or any components typically associated with IVD devices.
- Lack of IVD-related information: The document does not contain any information related to the analysis of biological samples, diagnostic markers, or any other elements characteristic of IVD devices.
Therefore, this device falls under the category of a medical device used for protection and hygiene during patient examination, not an in vitro diagnostic device.
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.
Product codes (comma separated list FDA assigned to the subject device)
LYZ
Device Description
The proposed device is a disposable device intended for over the counter use. It is not made with natural rubber latex. Instead, the gloves are formulated using vinyl synthetic polymer. The glove is coated with an emollient coating. The gloves are manufactured using molds that are ambidextrous. They are offered powder-free and 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)
Non-clinical tests were conducted for determination of substantial equivalence.
- Biocompatibility: Primary Skin Irritation (ISO 10993-10) was Non-irritating. Guinea Pig Maximization (ISO 10993-10) was Non-sensitizing.
- Physical Characteristics: Dimensions (ASTM D5250) met requirements. Physical Properties (ASTM D5250) met requirements for vinyl examination gloves. Freedom from Holes (21 CFR 800.20 & ASTM D5250) was tested in accordance with ASTM D 5151 with acceptable results; meets requirements of AQL 2.5. Powder Residual (ASTM D5250 tested using ASTM standard D6124) met powder level requirements for "Powder-Free" designation per ASTM D5250. Results generated values
§ 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an emblem featuring a stylized depiction of three human profiles facing right, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 25, 2016
Cardinal Health, Inc. Megan Middaugh Manager, Regulatory Affairs 1500 Waukegan Road Waukegan, IL 60085
Re: K160411
Trade/Device Name: Cardinal Health™ Vinyl Powder-Free Exam Gloves with Neu-Thera® Coating (Esteem® Synthetic with Neu-Thera®) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: June 13, 2016 Received: June 14, 2016
Dear Ms. Middaugh:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
1
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160411
Device Name
Cardinal Health™ Vinyl Powder-Free Exam Gloves with Neu- thera® Coating (Esteem® Synthetic with Neu-Thera®)
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a stylized red bird-like design above the company name. The company name "CardinalHealth" is written in a bold, sans-serif font, with "Cardinal" in black and "Health" in a slightly darker shade of black.
Cardinal Health 1500 Waukegan Road Waukegan, IL 60085 cardinalhealth.com
Page 1 of 5
510(k) SUMMARY
Cardinal Health™ Vinyl Powder-Free Exam Gloves with Neu-thera® Coating (Esteem® Synthetic with Neu-Thera®)
| Manufacturer: | Cardinal Health 200, LLC
1500 Waukegan Road
Waukegan, IL 60085 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Megan Middaugh
1500 Waukegan Road
Waukegan, IL 60085 |
| Telephone Number: | (847) 887-6812 |
| Fax Number: | (847) 887-2461 |
| Date Summary Prepared: | July 14, 2016 |
| Product Trade Name: | Cardinal Health™ Vinyl Powder-Free Exam Gloves with Neu
Thera® Coating (Esteem® Synthetic with Neu-Thera®) |
| Common Name: | Examination Gloves |
| Classification Name: | Patient Examination Gloves |
| Classification Panel: | General Hospital and Personal Use Devices |
| Regulation: | 21 CFR 880.6250 |
| Product Code: | LYZ |
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Image /page/4/Picture/1 description: The image shows the Cardinal Health logo. The logo consists of a stylized red graphic above the company name. The graphic is composed of several curved lines that resemble a bird in flight. The company name, "CardinalHealth," is written in a bold, sans-serif font, with "Cardinal" in regular weight and "Health" in bold.
510(K) SUMMARY (CONT'D)
| Predicate Devices: | K052568 - Cardinal Health's Esteem Stretchy Synthetic with Neu-Thera® Powder-Free Exam Gloves |
|---|---|
| Reason for 510(k) Submission: | Modification of a legally marketed device |
| Device Description: | The proposed device is a disposable device intended for over the counter use. It is not made with natural rubber latex. Instead, the gloves are formulated using vinyl synthetic polymer. The glove is coated with an emollient coating. The gloves are manufactured using molds that are ambidextrous. They are offered powder-free and non-sterile. |
| Intended 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. |
| Substantial Equivalence: | The proposed device is substantially equivalent to the predicate device identified in this 510(k) summary. Substantial equivalence can be established in regard to intended use, physical properties and characteristics, design and product features. Both gloves are made of synthetic vinyl using the same manufacturing process. |
5
Table 1: Summary of Technological Characteristics
| Summary of the technological characteristics of the device compared to the predicate device | ||
|---|---|---|
| Characteristic | Subject Device | Predicate Device |
| Material | ||
| Composition | Cardinal Health™ Vinyl Powder-Free | |
| Exam Gloves with Neu-Thera® Coating | ||
| (Esteem® Synthetic with Neu-Thera®) | Cardinal Health's Esteem Stretchy | |
| Synthetic with Neu-Thera® Powder-Free Exam Gloves (K052568) | ||
| Material | ||
| Composition | Vinyl | |
| Coated with emollient coating | Vinyl | |
| Coated with emollient coating | ||
| Design | Ambidextrous | |
| Beaded cuff | ||
| Lubricated | Ambidextrous | |
| Beaded cuff | ||
| Lubricated | ||
| Intended 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. | 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. | ||
| Label Claims | Single Use Only | |
| Non-sterile | ||
| Powder-free | ||
| Not made with natural rubber latex | ||
| Coated with proprietary formulation | Single Use Only | |
| Non-sterile | ||
| Powder-free | ||
| Not made with natural rubber latex | ||
| Coated with proprietary formulation | ||
| Dimensions & | ||
| Physical | ||
| Properties | Meets ASTM D5250 | Meets ASTM D5250 |
| Freedom from | ||
| Holes | Meets 21CFR 800.20 & ASTM D5250 | |
| requirements of AQL 2.5 | Meets 21CFR 800.20 & ASTM D5250 | |
| requirements of AQL 2.5 | ||
| Powder Residual | Meets requirements of ≤2.0 mg/glove for | |
| Powder-Free designation per ASTM | ||
| D5250 | Meets requirements of ≤2.0 mg/glove | |
| for Powder-Free designation per ASTM | ||
| D5250 |
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Table 2: Summary of Non-Clinical Tests
| PERFORMANCE DATA | ||
|---|---|---|
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION | ||
| OF SUBSTANTIAL EQUIVALENCE | ||
| Performance Test Summary-New Device | ||
| Characteristic | Standard/Test/FDA | |
| Guidance | Results Summary | |
| Biocompatibility: | ||
| Primary Skin | ||
| Irritation | ISO 10993-10 | Non-irritating |
| Guinea Pig | ||
| Maximization | ISO 10993-10 | Non-sensitizing |
| Physical Characteristics: | ||
| Dimensions | ASTM D5250 | Meets requirements |
| Physical Properties | ASTM D5250 | Meet requirements for vinyl examination |
| gloves | ||
| Freedom from Holes | 21 CFR 800.20 & | |
| ASTM D5250 | Tested in accordance with ASTM D 5151 | |
| with acceptable results; Meets | ||
| requirements of AQL 2.5 | ||
| Powder Residual | ASTM D5250 tested | |
| using ASTM | ||
| standard D6124 | Gloves meet powder level requirements for | |
| "Powder-Free" designation per ASTM | ||
| D5250. Results generated values |