(32 days)
Not Found
Not Found
No
The device is a standard examination glove and the summary contains no mention of AI or ML.
No
The device is described as a glove intended to prevent contamination between patient and examiner, not to treat or cure a disease or condition.
No
The device is described as an examination glove, which is used for protection and contamination prevention, not for diagnosing medical conditions.
No
The device is a physical examination glove, which is a hardware medical 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 barrier device used for physical protection, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical properties and standards met by the glove (ASTM and FDA regulations for gloves). It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Reagents or assays
- Providing diagnostic information
- Use in a laboratory setting for testing
Therefore, based on the provided text, the device is a medical device intended for barrier protection, 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)
LYY
Device Description
The Powder Free Blue Latex Examination Glove, Non-sterile (Protein Content Labeling) meets all the requirements of ASTM standard D 3578 - 01 Type I 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 / medical purposes
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 Blue Latex Examination Glove, Non-sterile (Protein Content Labeling) is summarized with the following technological characteristics compared to ASTM or equivalent standards: Dimensions (ASTM D 3578 - 01, Meets), Physical Properties (ASTM D 3578 - 01, Meets), Freedom from pinholes (ASTM D 3578 - 01, FDA 21 CFR 800.20, Meets), Powder-Free (ASTM D 6124 - 00,
§ 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
Submitter: 1.0
| Name : | WRP Specialty Products Sdn. Bhd. |
|---|---|
| Address : | Lot 11, Jalan 2, Kawasan Perusahaan Bandar Baru Salak |
| Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA | |
| Phone No. : | +60 3 8706 9788 |
| Fax No. : | +60 3 8706 5020 |
November 09, 2001 Date of Summary Prepared :
Contact Person: 2.0
| Name: | Mr. Mohd Haizan Hussein |
|---|---|
| Phone No.: | +603 8706 9788 |
| Fax No.: | +603 8706 5020 |
Name of the device: 3.0
| 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 Blue Latex Examination Glove, Non-sterile (Protein Content Labeling) |
Identification of The Legally Marketed Device: 4.0
Class I patient examination gloves, 80LYY, powder free, that meets all the State - Patison ASTM standard D 3578 - 01 Type I and FDA 21 CFR 800.20.
Description of The Device: 5.0
The Powder Free Blue Latex Examination Glove, Non-sterile (Protein Content Labeling) meets all the requirements of ASTM standard D 3578 - 01 Type I and FDA 21 CFR 800.20.
1
6.0 Intended Use of the Device:
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.
7.0 Summary of the Technological Characteristics of the Device:
The Powder Free Blue Latex Examination Glove, Non-sterile (Protein Content Labeling) is summarized with the following technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578 - 01 | Meets |
| Physical Properties | ASTM D 3578 - 01 | Meets |
| Freedom from pinholes | ASTM D 3578 - 01 | |
| FDA 21 CFR 800.20 | Meets | |
| Powder-Free | ASTM D 6124 - 00 |