(28 days)
Not Found
Not Found
No
The device is a standard examination glove and the summary contains no mention of AI or ML technology.
No.
The device is described as an examination glove intended to prevent contamination, not to treat or diagnose a medical condition.
No
The intended use states it is for preventing contamination, not for diagnosis.
No
The device is a physical product (gloves) and not software. The description focuses on material properties and physical tests.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hand. This is a barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description focuses on material properties and leak testing, which are relevant to a barrier device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing information for diagnosis.
- Anatomical Site: The device is worn on the examiner's hand, not used to collect or analyze a sample from a patient.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not perform any such function.
N/A
Intended Use / Indications for Use
The Powder Free Latex Examination Gloves, Blue, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) 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 Latex Examination Gloves, Blue, Non-Sterile (Contains 50 micrograms or less of Water Extractable Protein per gram) is a disposable device and made of Natural Rubber Latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Product codes
LYY
Device Description
The Powder Free Latex Examination Gloves, Blue, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) meets all the requirements of ASTM standard D 3578 - 01a22 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
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner / 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)
Not Found
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
JUL 2 8 2003
Image /page/0/Picture/1 description: The image shows a logo with the letters "WRP" in white against a black background. The letters are bold and slightly stylized, with the "W" and "R" connected at the top. To the right of the logo, there is a partial letter "P" in black, suggesting that there may be more text or another element that is cut off in the image.
P Buana Multicorpora
KO3 2007
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
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 : June 9 , 2003
2.0 Contact Person :
| Name | :Mr. Ng Poy Sin |
|---|---|
| Phone No. | :+61 6942461, 6942462 |
| Fax No. | :+61 6942463 |
Name of the device : 3.0
| Trade Name | 1). Glovetex, and
2). Multiple or Customers' Trade Name |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Powder Free Latex Examination Gloves, Blue, Non-Sterile
Contains 50 micrograms or less of Total Water Extractable Protein per gram |
| Common Name | Examination Gloves |
| Classification Name | Patient Examination Gloves (Class I) |
Identification of The Legally Marketed Device : 4.0
Class I patient examination gloves, 80LYY, powder free, that meets all the requirements of ASTM standard D 3578 -- 01a22 and FDA 1000 ml Water Leak Test.
5.0 Description of The Device :
The Powder Free Latex Examination Gloves, Blue, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) meets all the requirements of ASTM standard D 3578 - 01a22 and FDA 1000 ml Water Leak Test.
6.0 Intended Use of the Device :
The Powder Free Latex Examination Gloves, Blue, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) 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 the logo for "PT. WRP Buana Multicorpora". The logo consists of the letters "WRP" in a stylized, bold font, enclosed in a black shape. To the right of the logo is the text "PT. WRP Buana Multicorpora" in a bold, sans-serif font.
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 Latex Examination Gloves, Blue, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | D 3578 - 01aᵉ² | Meets |
| Physical Properties | D 3578 - 01aᵉ² | Meets |
| Freedom from Pinholes | D 3578 - 01aᵉ² | |
| FDA 21 CFR 800.20 | Meets | |
| Powder Residue | D 3578 - 01aᵉ² | |
| D 6124 - 01 |