(50 days)
80LZA
80LZA
No
The 510(k) summary describes standard examination gloves and does not mention any AI or ML capabilities.
No.
The device is described as an examination glove intended to prevent contamination, not to treat or diagnose a medical condition.
No
The device is a glove, which is used for protection against contamination, not for diagnosing medical conditions.
No
The device description clearly states it is a physical product (gloves made of synthetic rubber) and does not mention any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for 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, not on any diagnostic function.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition.
- Predicate Device: The predicate device is also a patient examination glove, reinforcing its classification as a barrier device.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This glove's function is purely protective.
N/A
Intended Use / Indications for Use
The Powder Free Nitrile Examination Glove, Blue, 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 Nitrile Examination Gloves, Blue, Non Sterile meets all the requirements of ASTM standard D 6319 – 00a83 and FDA 1000 ml Water Leak Test.
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 performance test data of the non-clinical tests that support a determination of substantial equivalent 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)
Class I patient examination gloves, 80LZA, powdered, that meets all the requirements of ASTM standard D 6319 – 00a83 and FDA 1000 ml Water Leak Test.
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
Image /page/0/Picture/0 description: The image shows the text "PT. WRP Buana Multicorpora" in bold, black font. The text appears to be the name of a company. The text is horizontally aligned and takes up most of the image space. The background is plain white.
K03 2010
Jalan Jermal No. 20-B, Kelurahan Sei Mati, Medan-Labuhan Km 17, INDONESIA
| Tel | + 62-61-6942461 |
|---|---|
| + 62-61-6942462 | |
| Fax | + 62-61-6942463 |
| URL | www.wrpworld.com |
:
AUG 1 9 2003
510 (K) SUMMARY
1.0 Submitter :
| Name | : PT. WRP Buana Multicorpora |
|---|---|
| Address | : Jl. Jermal No.20B Kelurahan Sei Mati |
| Medan Labuhan KM 17, INDONESIA. | |
| Phone No. | : +61 6942461, 6942462 |
| Fax No. | : +61 6942463 |
Date of Summary Prepared : 29 July, 2003
2.0 Contact Person :
| Name | : Mr. Ng Poy Sin |
|---|---|
| Phone No. | : +61 6942461, 6942462 |
| Fax No. | : +61 6942463 |
3.0 Name of the device :
| Trade Name | 1). Glovetex, and |
|---|---|
| 2). Multiple or Customers' Trade Name | |
| Device Name | Powder Free Nitrile Examination Gloves, Blue, Non-Sterile |
| Common Name | Examination Gloves |
| Classification Name | Patient Examination Gloves (Class I) |
4.0 ldentification of The Legally Marketed Device :
Class I patient examination gloves, 80LZA, powdered, that meets all the requirements of ASTM standard D 6319 – 00a83 and FDA 1000 ml Water Leak Test.
5.0 Description of The Device :
The Powder Free Nitrile Examination Gloves, Blue, Non Sterile meets all the requirements of ASTM standard D 6319 – 00a83 and FDA 1000 ml Water Leak Test.
6.0 Intended Use of the Device :
The Powder Free Nitrile Examination Glove, Blue, 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.
1
Image /page/1/Picture/0 description: The image shows a logo with the letters "WRP" in a bold, sans-serif font. The letters are white and stand out against a black background. The logo has a slightly distressed or textured appearance, giving it a vintage or worn look. The overall shape of the logo is somewhat hexagonal or rounded, with the letters fitting snugly within the shape.
RP Buana Multicorpora
Image /page/1/Picture/2 description: The image shows a handwritten text that appears to read "KB2010". The text is written in a cursive style with thick, dark lines, making it easily readable against the white background. The characters are connected, giving the impression of a single, continuous stroke for each word. The overall impression is that of a quick, informal note or label.
Jalan Jermal No. 20-B, Kelurahan Sei Mati, Medan-Labuhan Km 17, INDONESIA
Tel +62-61-6942461 +62-61-6942462 Fax +62-61-6942463 URL www.wrpworld.com
7.0 Summary of The Technological Characteristics of The Device :
The Powder Free Nitrile Latex Examination Gloves, Blue, Non Sterile are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE
PERFORMANCE |
|-----------------------|---------------------------------------|----------------------------------------|
| Dimensions | D 6319 - 00ae3 | Meets |
| Physical Properties | D 6319 - 00ae3 | Meets |
| Freedom from Pinholes | D 6319 - 00ae3
FDA 21 CFR 800.20 | Meets |
| Powder Free Residue | D 6124 - 01 | Meets