(50 days)
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No
The document describes standard examination gloves and makes no mention of AI or ML.
No.
The device (examination gloves) is intended to prevent contamination, not to treat a disease or condition.
No
The device is described as "Powder Free White Nitrile Examination Gloves," which are intended to prevent contamination between patient and examiner. There is no mention of the device being used to diagnose any condition or disease.
No
The device is described as physical gloves made of synthetic rubber, intended to be worn on the hand or finger. There is no mention of software components or functionality.
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 gloves are "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description focuses on material and performance standards related to barrier integrity (ASTM standard and water leak test).
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Predicate Device: The predicate device is also described as "patient examination gloves," reinforcing the non-diagnostic nature.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Powder Free White Nitrile 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.
Powder Free White Nitrile Examination Gloves, Non-Sterile is a disposable device and made of Synthetic Rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
The Powder Free White Nitrile Examination Gloves, Non sterile meets all the requirements of ASTM standard D 6319 – 00a83 and FDA 1000 ml Water Leak Test.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hand or finger
Indicated Patient Age Range
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Intended User / Care Setting
examiner
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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.)
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 a logo with the letters "WRP" in white against a black, rounded hexagonal background. The letters are bold and sans-serif, with the "W" being the widest and the "P" being the narrowest. The logo has a slightly distressed or textured appearance, giving it a vintage or worn look. The overall design is simple and eye-catching.
PT. WRP Buana Multicorpora
Image /page/0/Picture/2 description: The image shows a handwritten text that appears to be a combination of letters and numbers. The text is "KO32011". The writing is in black ink on a white background. The text is slightly tilted.
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 |
:"
i
1.1 ... (1)
510 (K) SUMMARY
AUG 1 9 2003
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 White Nitrile Examination Gloves, 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, powder free, 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 White Nitrile Examination Gloves, 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 White Nitrile 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.
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Page 1 of 2
Your Partner In Protection™
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Image /page/1/Picture/0 description: The image shows the text "PT. WRP Buana Multicorpora" in a bold, sans-serif font. The text is arranged horizontally, with each word clearly legible. The overall impression is that of a company name or title, presented in a straightforward and professional manner.
Image /page/1/Picture/1 description: The image shows a handwritten text that appears to be a signature or code. The text includes the letters 'Ko' followed by the numbers '32011'. The text is written in black ink on a white background and has a slightly tilted orientation.
Jalan Jermal No. 20-B, Kelurahan Sei Mati, Medan-Labuhan Km 17, INDONESIA
+62-61-6942461 Tel +62-61-6942462 Fax +62-61-6942463 www.wrpworld.com URL
Summary of The Technological Characteristics of The Device : 7.0
The Powder Free White Nitrile Examination Gloves, 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