(48 days)
Not Found
Not Found
No
The 510(k) summary describes standard examination gloves and does not mention any AI or ML components or functionalities.
No
The device, "Powder Free Neoprene Examination Gloves, Non Sterile", is described as a disposable device intended for medical purposes worn on the examiner's hand to prevent contamination. This function is preventative, not therapeutic.
No
The intended use of the device, examination gloves, is to prevent contamination between patient and examiner. There is no mention of diagnostic purposes.
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 "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description focuses on physical properties and standards related to gloves, not on analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on physical characteristics and biocompatibility of the glove material, not on diagnostic accuracy or performance.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Powder Free Neoprene Examination Gloves, Non-Sterile is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
The Powder Free Neoprene Examination Gloves, Non Sterile meets all the The Towder 1160 - Neopandard D 3578 - 00 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
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)
The Powder Free Neoprene Examination Gloves, Non Sterile are summarized with the following technological characteristics compared to ASTM or equivalent standards:
Dimensions: Meets ASTM D 3578 - 00
Physical Properties: Meets ASTM D 3578 - 00
Freedom from pinholes: Meets ASTM D 3578 - 00, FDA 21 CFR 800.20
Powder-Free: Meets 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
WRP Asia Pacific Sdn Bhd
AUG 1 6 2001
Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALA YSIA
MALAYSIA
+60-3-8706 1486 TEL +60-3-8706 1485 FAX EML cyw wrp@wrpworld.com URL www.wrpworld.com
510(k) SUMMARY
Submitter: 1.0
| Name: | WRP Asia Pacific Sdn Bhd |
|---|---|
| Address: | Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak |
| Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA | |
| Phone No.: | +60 3 8706 1486 |
| Fax No.: | +60 3 8706 1485 |
Date of Summary Prepared: June 14, 2001
Contact Person: 2.0
| Name: | Mr. Yue Wah, CHOW |
|---|---|
| Phone No.: | +60 3 8706 1486 |
| Fax No.: | +60 3 8706 1485 |
3.0 Name of the device:
| Trade Name: | 1. DermaSafe, and |
|---|---|
| 2. Multiple or Customer's Trade Name | |
| Device Name: | Powder Free Neoprene Examination Gloves, Non-Sterile |
| Common Name: | Examination Gloves |
| Classification Name: | Patient Examination Gloves (per 21 CFR 880.6250) |
Identification of The Legally Marketed Device: 4.0
Class I patient examination gloves, 80LZA, powder free, that meets all the Class - 1 patient - C.TM standard D 3578 - 00 and FDA 21 CFR 800.20.
Description of The Device: 5.0
The Powder Free Neoprene Examination Gloves, Non Sterile meets all the The Towder 1160 - Neopandard D 3578 - 00 and FDA 21 CFR 800.20.
Page 1 of 3
1
Image /page/1/Picture/0 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in a bold, sans-serif font, with the letters in white against a black background. To the right of the letters is the company name, "WRP Asia Pacific Sdn Bhd," in a smaller, sans-serif font.
Intended Use of the Device: 6.0
Clarron Eng All Dononna"
The Powder Free Neoprene Examination Gloves, Non-Sterile is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Summary of The Technological Characteristics of The Device: 7.0
The Powder Free Neoprene Examination Gloves, Non Sterile are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE
PERFORMANCE |
|-----------------------|---------------------------------------|-----------------------------------------|
| Dimensions | ASTM D 3578 - 00 | Meets |
| Physical Properties | ASTM D 3578 - 00 | Meets |
| Freedom from pinholes | ASTM D 3578 - 00
FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 - 00 | Meets