(45 days)
Not Found
No
The device is a simple examination glove with no mention of AI/ML capabilities or data processing.
No
The device is described as a disposable glove intended to prevent contamination, not to treat or cure a disease or condition.
No
Explanation: The device, a non-sterile examination glove, is intended to prevent contamination between patient and examiner. It does not collect or analyze data to provide diagnostic information about a patient's condition.
No
The device is a physical examination glove, not a software application. The description focuses on material properties and physical standards.
Based on the provided text, 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 during physical examination, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical characteristics and standards met (ASTM, FDA 21 CFR 800.20), which are typical for medical gloves. It also mentions a change in color additive, which is irrelevant to IVD functionality.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, this device is a medical glove, not an IVD.
N/A
Intended Use / Indications for Use
The Powder Free Pink Nitrile Examination Gloves, 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)
LZA
Device Description
The Powder Free Pink Nitrile Examination Gloves, Non Sterile is equivalent to the existing model, i.e. Powder Free Blue Nitrile Examination Gloves, Non Sterile which had submitted and cleared under 510(k) number K022904. The difference in this submission is: Change of colour additive used, i.e. Pink. The modification of colour does not affect the intended use of the device as well as it does not affect its safety and effectiveness. The indication for use and proposed labeling for the device are illustrated in subsequent sections. The Powder Free Pink Nitrile Examination Gloves, Non-Sterile meets all the requirements of ASTM standard D 6319 - 00a23 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 / medical purposes
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 Pink Nitrile Examination Gloves, Non-Sterile are summarized with the following technological characteristics compared to ASTM or equivalent standards:
- Dimensions: Meets ASTM D 6319 - 00aE3
- Physical Properties: Meets ASTM D 6319 - 00aE3
- Freedom from pinholes: Meets ASTM D 6319 - 00aE3 and FDA 21 CFR 800,20
- Powder Residual: Meets 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/1 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, 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".
DEC 0 2 2002
SPECIAL 510(k) SUMMARY
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 |
17 OCT 2002 Date of Summary Prepared:
2.0 Contact Person:
| Name: | Mr. Terence Lim |
|---|---|
| Phone No.: | +60 3 8706 1486 |
| Fax No.: | +60 3 8706 1485 |
3.0 Modified Device Identification:
| Trade Name: | 1) Dermagrip-P, and |
|---|---|
| 2) Multiple or Customers' Trade Name | |
| Device Name: | Powder Free Pink Nitrile Examination Gloves, Non-Sterile |
| Common Name: | Examination Gloves |
| Classification Name: | Patient Examination Gloves (per 21 CFR 880.6250) |
Identification of the Legally Marketed Device: 4.0
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 Device Modification:
The Powder Free Pink Nitrile Examination Gloves, Non Sterile is equivalent to the existing model, i.e. Powder Free Blue Nitrile Examination Gloves, Non Sterile which had submitted and cleared under 510(k) number K022904.
1
11023517
Image /page/1/Picture/1 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, enclosed in a black oval shape. To the right of the logo is the company name, "WRP Asia Pacific Sdn Bhd," also in a bold, sans-serif font. Below the company name is the number 147017V.
The difference in this submission is:
- Change of colour additive used, i.e. Pink a)
The modification of colour does not affect the intended use of the device as well as it does not affect its safety and effectiveness. The indication for use and proposed labeling for the device are illustrated in subsequent sections.
The Powder Free Pink Nitrile Examination Gloves, Non-Sterile meets all the requirements of ASTM standard D 6319 - 00a23 and FDA 21 CFR 800,20.
4,0 Intended Use of the Device:
The Powder Free Pink Nitrile Examination Gloves, 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.
5.0 Summary of Technological Characteristics for the Modified Device:
The Powder Free Pink 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
|
|----------------------|----|------------------|--------------------------|
| (Per 21 CFR 801.109) | | | |
Susan Runor
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number | K023517 |
|---|---|
| --------------- | --------- |