(92 days)
Not Found
Not Found
No
The device is a medical glove and the summary does not mention any AI or ML components.
No
The device is a glove intended to prevent contamination, not to treat or diagnose a medical condition.
No
Explanation: The device is an examination glove, used to prevent contamination, not to diagnose a condition. Its intended use and description clearly state it's for protection and not for diagnostic purposes.
No
The device is a physical glove, not software. The description clearly states it is a "disposable device intended for medical purposes that is worn on the examiner's hand".
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a glove worn on the examiner's hand to prevent contamination between patient and examiner. This is a barrier device for personal protection and infection control.
- Device Description: The description focuses on the physical properties of the glove and its compliance with standards for examination gloves.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically reagents, instruments, or systems used for such purposes.
The device is a medical device, specifically a Class I patient examination glove, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Powder Free Latex Examination Gloves Coated with Skin-care ingredients and with Protein Content Labeling Claim are disposable devices 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 Latex Examination Gloves Coated with Skin-care ingredients and with Protein Content Labeling Claim (50 micrograms or less) meets all the requirements of ASTM standard D 3578 - 01a52 and FDA 21 CFR 800.
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 equivalence 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.)
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | ASTM D 3578 - 01aE2 | Meets |
| Physical Properties | ASTM D 3578 - 01aE2 | Meets |
| Freedom from pinholes | ASTM D 3578 - 01aE2 FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 - 01 |
§ 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 letters "WRP" in white against a black background. The letters are bold and slightly slanted to the right. The background is a rounded rectangle shape.
WRP Asia Pacific Sdn Bhd
510(k) SUMMARY
JAN | 6 2003
1.0 Submitter:
| Name: | WRP Asia Pacific Sdn. Bhd. |
|---|---|
| Address: | Lot 1, Jalan 3, Kawasan Perushaan Bandar Baru Salak Tinggi, |
| 43900 Sepang, Selangor Darul Ehsan, MALAYSIA | |
| Phone No.: | +60 3 8706 1486 |
| Fax No.: | +60 3 8706 1485 |
1 4 OCT 2002 Date of Summary Prepared:
2.0 Contact Person:
| 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. DermaGrip-X, and
2. Multiple or Customer's Trade Name |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Powder Free Latex Examination Gloves Coated with Skin care
Ingredients (Vitamin A, Vitamin B, Vitamin E, α-Lipoic acid,
Eucalyptus, Jojoba and Emollient Cream) and with Protein Content
Labeling Claim (50 micrograms or less) |
| Common Name: | Examination Gloves |
| Classification Name: | Patient Examination Gloves (per 21 CFR 880.6250) |
4.0 Identification of The Legally Marketed Device:
Class I patient examination gloves, 80LYY, powder free, that meets all the requirements of ASTM standard D 3578 - 01a52 and FDA 21 CFR 800.20.
5.0 Description of The Device:
The Powder Free Latex Examination Gloves Coated with Skin-care ingredients and with Protein Content Labeling Claim (50 micrograms or less) meets all the requirements of ASTM standard D 3578 - 01a52 and FDA 21 CFR 800.
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 enclosed in a rounded, black shape. To the right of the logo is the text "WRP Asia Pacific Sdn Bhd" in a similar font. Below the text is the number "1 4 7 8 1 7 V".
Intended Use of the Device: 6.0
The Powder Free Latex Examination Gloves Coated with Skin-care ingredients and with Protein Content Labeling Claim are disposable devices 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 Latex Examination Gloves Coated with Skin-care ingredients and with Protein Content Labeling Claim are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | ASTM D 3578 - 01aE2 | Meets |
| Physical Properties | ASTM D 3578 - 01aE2 | Meets |
| Freedom from pinholes | ASTM D 3578 - 01aE2 | |
| FDA 21 CFR 800.20 | Meets | |
| Powder-Free | ASTM D 6124 - 01 |