(83 days)
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No
The device is a standard medical glove and the description focuses on material properties and performance standards, with no mention of AI or ML.
No.
The device (a medical glove) is intended to prevent contamination between personnel and patients, acting as a barrier. It does not directly treat or prevent a disease, or restore, modify, or correct body function or structure, which are characteristic functions of a therapeutic device.
No
This device, a medical glove, is intended to prevent contamination and is not described as diagnosing any condition or disease.
No
The device is a physical medical glove, not a software-only device. The description clearly states it is a "medical glove intended to be worn on the hands" and describes its physical properties and standards.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between healthcare personnel and the patient by being worn on the hands. This is a barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical properties and standards met by the glove (ASTM D 3578-00a), not on any diagnostic capabilities.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the glove's barrier properties and meeting standards, not on diagnostic accuracy metrics like sensitivity, specificity, etc.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not fit that description.
N/A
Intended Use / Indications for Use
A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient.
Product codes
LYY
Device Description
The powder-free latex exam glove with vitamin E and aloe are disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hands
Indicated Patient Age Range
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Intended User / Care Setting
healthcare and similar personnel
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance test data that support a determination of substantial equivalence are described above.
Clinical data are not needed for examination gloves.
It can be concluded that the powder-free latex exam glove with vitamin E and aloe is safe and effective according to the glove performance standards referenced in and will be perfected using ASTM standards, FDA requirements, and the labeling claims for the product. Consequently, this exam glove is substantially equivalent to currently marketed exam gloves.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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/0 description: The image shows the Kimberly-Clark logo. The logo consists of a stylized "K" inside a circle on the left, followed by the words "Kimberly-Clark" in bold, sans-serif font. The logo is black and white.
NOV 1 3 2001
August 21, 2001
- [1] 510(k) Summary of Safety and Effectiveness Information
[2] Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, GA 30076-2199 Telephone: 770-587-8000 770-587-7762 Fax:
Contact: Marcia Johnson Telephone: 770-587-8324 Fax: 770-587-7762
- "SAFESKIN HEALTHTOUCH" Powder-Free Latex Exam Glove [3] Trade Name: with Vitamin E and Aloe Patient Examination Gloves, Latex Common Name: Classification Name: Patient Examination Gloves, Latex
- [4] The predicate device is a Class I, powder-free latex exam glove 80L Y Y that meets all of the requirements of ASTM D 3578-00a, Standard Specification for Rubber Examination Gloves.
- The powder-free latex exam glove with vitamin E and aloe meets the current [૨] specifications for ASTM D 3578-00a.
- [୧] The powder-free latex exam gloves with vitamin E and aloe are disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient.
- [7] The powder-free latex exam gloves with vitamin E and aloe possess the following technological characteristics (as compared to ASTM or equivalent standards):
| Characteristics | Standards |
|---|---|
| Dimensions | Meets ASTM D 3578-00a |
| Physical Properties | Meets ASTM D 3578-00a |
| Freedom from pinholes | Meets ASTM D 3578-00a |
| Meets ASTM D 5151-99 | |
| Powder Free | Meets ASTM D 6124-00a |
| Meets ASTM D 3578-00a |
G2
1
Image /page/1/Picture/0 description: The image shows the Kimberly-Clark logo. The logo consists of a stylized symbol on the left, followed by the company name "Kimberly-Clark" in bold, sans-serif font. The symbol appears to be a stylized cross or geometric shape enclosed within a circle.
Protein Content
Meets ASTM D 5712-99