(72 days)
Not Found
Not Found
No
The device is a surgical glove and the description focuses on material properties and performance standards, with no mention of AI or ML.
No
The device is a surgical glove intended to prevent contamination, not to treat or cure a disease or condition.
No.
The device is a surgical glove, intended to prevent contamination and protect wounds, not to diagnose medical conditions.
No
The device description clearly states it is a physical glove made of synthetic rubber latex, 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 that the gloves are for preventing contamination between healthcare personnel and the patient's body, fluids, waste, or environment, and for protecting a surgical wound from contamination. This is a barrier function, not a diagnostic function.
- Definition of IVD: An IVD is a medical device used to perform tests on samples such as blood, urine, or tissue to detect diseases, conditions, or infections. The description of the gloves does not involve any testing of samples.
- Device Description: The description focuses on the material, sterility, and compliance with standards related to glove performance (ASTM and FDA regulations for gloves). There is no mention of reagents, assays, or any components typically associated with IVDs.
- Performance Studies and Metrics: The performance studies and key metrics listed are related to the physical properties, integrity (pinholes), powder content, and biocompatibility of the gloves. These are relevant to the barrier function and safety of the device, not to diagnostic accuracy.
In summary, the device is a surgical glove intended for protection and contamination prevention, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Powder Free Neoprene Surgical Glove, Sterile, Turquoise Colour and coated with Aloe Vera is made of synthetic rubber latex intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.
The surgeon's glove is a device made of synthetic rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.
Product codes (comma separated list FDA assigned to the subject device)
KGO
Device Description
The Powder Free Neoprene Surgical Glove, Sterile, Turquoise Colour and coated with Aloe Vera meets all the requirements of ASTM standard D 3577 - 01a22 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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare personnel, operating room personnel and similar personnel
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.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).
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, with the words "WRP Asia Pacific Sdn Bhd" written to the right of the letters. Below the company name is the number 147817V.
NOV - 7 2003
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 1557 |
Date of Summary Prepared: 25 AUG 2003
2.0 Contact Person:
| Name: | Mr. Terence Lim |
|---|---|
| Phone No.: | +60 3 8706 1486 |
| Fax No.: | +60 3 8706 1557 |
3.0 Name of the device:
| Trade Name: | 1. Aloetouch, and
2. Multiple or Customer's Trade Name |
|----------------------|-------------------------------------------------------------------------------------------|
| Device Name: | Powder Free Neoprene Surgical Glove, Sterile, Turquoise Colour and coated with Aloe Vera. |
| Common Name: | Surgical Gloves |
| Classification Name: | Surgeon's Gloves (per 21 CFR 878.4460) |
Identification of The Legally Marketed Device: 4.0
Class I Powder Free Synthetic rubber latex Surgeon's gloves, 79KGO, that meets all
the requirements of ASTM standard D 3577 – 01a22 Type 2 and FDA 21 CFR 800.20.
5.0 Description of The Device:
The Powder Free Neoprene Surgical Glove, Sterile, Turquoise Colour and coated with Aloe Vera meets all the requirements of ASTM standard D 3577 - 01a22 and FDA 21 CFR 800.20.
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, enclosed in a black oval 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 "147817 V".
6.0 Intended Use of the Device:
The Powder Free Neoprene Surgical Glove, Sterile, Turquoise Colour and coated with Aloe Vera is made of synthetic rubber latex intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.
Summary of The Technological Characteristics of The Device: 7.0
The Powder Free Neoprene Surgical Gloves, Sterile, Turquoise Colour and coated with Aloe Vera are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE
PERFORMANCE |
|-----------------------|------------------------------------------|-----------------------------------------|
| Dimensions | ASTM D 3577 - 01aE2 | Meets |
| Physical Properties | ASTM D 3577 - 01aE2 | Meets |
| Freedom from pinholes | ASTM D 3577 - 01aE2
FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 - 01 | Meets