(30 days)
Not Found
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI, ML, image processing, or data analysis beyond standard performance testing for a glove.
No.
The device description clearly states its purpose is to "prevent contamination between patient and examiner," indicating it is a barrier device for examination purposes rather than a therapeutic intervention.
No
The device, Powder Free Blue Nitrile Examination Glove, Non Sterile, is described as a disposable device worn on the examiner's hand to prevent contamination. Its intended use does not mention diagnosis, detection, monitoring, or treatment of any disease or condition.
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 or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection during physical examination, not a device used to examine specimens taken from the body (which is the core function of an IVD).
- Device Description: The description focuses on the material (nitrile), form (powder-free), and standards it meets (ASTM and FDA regulations for gloves). There is no mention of reagents, assays, or any components typically associated with in vitro testing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or treatment based on sample analysis
In summary, the device is a medical glove intended for barrier protection, which falls under a different regulatory classification than IVDs.
N/A
Intended Use / Indications for Use
The Powder Free Blue Nitrile Examination Glove, Non Sterile 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.
Product codes (comma separated list FDA assigned to the subject device)
80 LZA
Device Description
The Powder Free Blue Nitrile Examination Gloves, Non Sterile meets all the requirements of ASTM standard D 6319 -- 00a53 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
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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 Blue Nitrile Examination Gloves, Non Sterile are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | ASTM D 6319 - 00aE3 | Meets |
| Physical Properties | ASTM D 6319 - 00aE3 | Meets |
| Freedom from pinholes | ASTM D 6319 - 00aE3 FDA 21 CFR 800.20 | Meets |
| Powder Residual | ASTM D 6124 - 01 | Meets |
§ 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 logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in a stylized font, followed by the words "WRP Asia Pacific Sdn Bhd" in a simpler font. Below the company name is the number "1 4 7 8 1 7 V".
510(k) SUMMARY
KC22904
1.0 Submitter:
Name: Address:
Phone No .:
Fax No.:
WRP Asia Pacific Sdn Bhd Lot 1, Jalan 3, Kawasan Perushaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA +60 3 8706 1486 460 3 8706 1485
2002 Date of Summary Prepared: 3 0 AUG
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-N, and
2) Multiple or Customers' Trade Name |
|----------------------|-------------------------------------------------------------|
| Device Name: | Powder Free Blue Nitrile Examination Gloves, Non-Sterile |
| Common Name: | Examination Gloves |
| Classification Name: | Patient Examination Gloves (per 21 CFR 880.6250) |
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 - 00a53 and FDA 21 CFR 800.20.
5.0 Description of The Device:
VA..... D....... ... T.. D... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The Powder Free Blue Nitrile Examination Gloves, Non Sterile meets all the requirements of ASTM standard D 6319 -- 00a53 and FDA 21 CFR 800.20.
TM
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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, stylized font inside of a rounded shape. To the right of the logo is the text "WRP Asia Pacific Sdn Bhd" in a standard font. Below the text is the number sequence "1 4 7 8 1 7 V".
6.0 Intended Use of the Device:
The Powder Free Blue Nitrile Examination Glove, Non Sterile 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.
7.0 Summary of The Technological Characteristics of The Device:
The Powder Free Blue Nitrile Examination Gloves, Non Sterile are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE
PERFORMANCE |
|-----------------------|------------------------------------------|-----------------------------------------|
| Dimensions | ASTM D 6319 - 00aE3 | Meets |
| Physical Properties | ASTM D 6319 - 00aE3 | Meets |
| Freedom from pinholes | ASTM D 6319 - 00aE3
FDA 21 CFR 800.20 | Meets |
| Powder Residual | ASTM D 6124 - 01 | Meets