(41 days)
Not Found
Not Found
No
The document describes a standard medical examination glove and explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
The device description states its purpose is to prevent contamination between patient and examiner, which is a barrier function, not a therapeutic one. It's a diagnostic aid/protective device, not for treatment or therapy.
No
Explanation: The device, a patient examination glove, is intended to prevent contamination between patient and examiner. It does not collect or analyze medical data to provide insights into a patient's health condition or make a diagnosis.
No
The device description clearly states it is a physical glove, which is a hardware 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 "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 from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the physical properties and standards met by the glove (ASTM standard D 3578 and FDA 21.CFR 800.20), which are typical for medical devices like gloves, not IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements characteristic of an in vitro diagnostic device.
Therefore, this device falls under the category of a medical device, specifically a patient examination glove, and not an IVD.
N/A
Intended Use / Indications for Use
The 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
80 LYY
Device Description
The Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Micrograms or less) meets all the requirements of ASTM standard D 3578 -- 01a"22 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
examiner
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 performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above. Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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.
0
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 |
2 1 AUG 2002 Date of Summary Prepared:
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 Latex Examination Gloves, Non-Sterile
with Protein Content Labeling Claim (50 Micrograms
or less) |
4.0 Identification of The Legally Marketed Device:
Class I patient examination gloves, 80LYY, powder free, that meets all the
requirements of ASTM standard D 3578 – 01a52 and FDA 21 CFR 800.20.
5.0 Description of The Device:
The Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Micrograms or less) meets all the requirements of ASTM standard D 3578 -- 01a"22 and FDA 21.CFR 800.20.
1
6.0 Intended Use of the Device:
The 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.
7.0 Summary of The Technological Characteristics of The Device:
The Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Micrograms or less) is summarized with the following technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578 01aE2 | Meets |
| Physical Properties | ASTM D 3578 01aE2 | Meets |
| Freedom from pinholes | ASTM D 3578 - 01aE2 | |
| FDA 21 CFR 800.20 | Meets | |
| Powder-Free | ASTM D 6124 01 |