(14 days)
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Not Found
No
The summary describes a standard examination glove and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML.
No
The device, a patient examination glove, is intended for preventing contamination, not for treating a disease or condition.
No
Explanation: The device is a patient examination glove, described as a barrier to prevent contamination between patient and examiner. There is no mention of it being used to diagnose conditions or process diagnostic information.
No
The device is a physical examination glove, which is a hardware device, 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 examiner's hand or finger to prevent contamination between patient and examiner." This describes a physical barrier device used during patient examination, not a device used to examine specimens in vitro (outside the body).
- Device Description: The description focuses on the material (nitrile), powder-free nature, and compliance with standards related to gloves. There is no mention of reagents, assays, or any components typically associated with in vitro testing.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing diagnostic information based on laboratory tests
Therefore, the intended use and description clearly indicate this is a medical device used for barrier protection during patient examination, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The patient examination glove is a disposable device intended for medical purposes The pation 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)
LZA
Device Description
The Powder Free Purple Nitrile Examination Gloves, Non Sterile meets all the requirements of ASTM standard D 6319 -- 00af1 and FDA 21 CFR 800.20.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
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)
The Powder Free Purple Nitrile Examination Gloves, Non Sterile is summarized with the following technological characteristics compared to ASTM or equivalent standards:
- Dimensions: Meets ASTM D 6319 – 00aEI
- Physical Properties: Meets ASTM D 6319 – 00dEI
- Freedom from pinholes: Meets ASTM D 6319 – 00dEI, FDA 21 CFR 800.20
- Powder-Free:
§ 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
MAY 1 6 2002
Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters, which appear to be a combination of letters and numbers. The sequence reads as 'KQ21396'. The characters are written in a cursive style, with some connections between them. The overall impression is that of a handwritten code or identifier.
510(k) Summary
1.0 Submitter:
| Name: | WRP Specialty Products Sdn Bhd. |
|---|---|
| Address: | Lot 11, Jalan 2, Kawasan Perushaan Bandar Baru Salak |
| Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA | |
| Phone No.: | +60 3 8706 9788 |
| Fax No.: | +60 3 8706 5020 |
Date of Summary Prepared: 30 APR 2002
2.0 Contact Person:
| Name: | V. Nadarajan |
|---|---|
| Phone No.: | +60 3 8706 9788 |
| Fax No.: | +60 3 8706 5020 |
3.0 Name of the device:
| Proprietary or Trade Name: | 1) Dermagrip, and |
|---|---|
| 2) Multiple or Customer's Trade Name | |
| Classification Name : | Patient Examination Gloves (per 21 CFR 880.6250) |
| Device Name : | Powder Free Purple Nitrile Examination Gloves, Non-Sterile |
Identification of The Legally Marketed Device: 4.0
Class I patient examination gloves, 80LZA, powder free, that meets all the
requirements of ASTM standard D 6319 - 00a" and FDA 21 CFR 800.20.
Description of The Device: 5.0
The Powder Free Purple Nitrile Examination Gloves, Non Sterile meets all the requirements of ASTM standard D 6319 -- 00af1 and FDA 21 CFR 800.20.
1
Intended Use of the Device: 6.0
The patient examination glove is a disposable device intended for medical purposes The pation on the examiner's hand or finger to prevent contamination between patient and examiner.
Summary of The Technological Characteristics of The Device: 7.0
The Powder Free Purple Nitrile Examination Gloves, Non Sterile is summarized with the following technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319 – 00aEI | Meets |
| Physical Properties | ASTM D 6319 – 00dEI | Meets |
| Freedom from pinholes | ASTM D 6319 – 00dEI | |
| FDA 21 CFR 800.20 | Meets | |
| Powder-Free | ASTM D 6124 – 01 |