(42 days)
Not Found
Not Found
No
The device description and intended use clearly define the product as surgical gloves, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The intended use of the device is to prevent contamination between personnel and patients, not to treat a disease or condition.
No
This device, surgical gloves, is intended to prevent contamination and protect wounds, not to diagnose a medical condition.
No
The device described is a physical medical device (surgical gloves) and does not involve any software component.
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 "intended to be worn on the hand of healthcare personnel... to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment." This describes a barrier device for protection, 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 material (natural rubber latex) and compliance with standards for gloves (ASTM D 3577-01a"2 and FDA 21 CFR 800.20). This aligns with the description of a medical device used for protection.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Powder Free Green Latex Surgical Gloves, Sterile with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less) are made of natural 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 natural rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.
Product codes
KGO
Device Description
The Powder Free Green Latex Surgical Gloves, Sterile with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less) meets all the requirements of ASTM standard D 3577-01a"2 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 / 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. (referring to the table in section 7.0)
| 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 2 mg/glove maximum |
| Protein Level | ASTM D 5712 - 95 |
§ 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
VRP Asia Pacific Sdn Bhd 1 4 7 8 1 7 V
KO22442
510(k) SUMMARY
1.0 Submitter:
| Name: | WRP Asia Pacific Sdn Bhd |
|---|---|
| Address: | Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak |
| Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA | |
| Phone No.: | +60 3 8706 1486 |
| Fax No .: | +60 3 8706 1485 |
22 JUL 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. Aloetouch, and
2. Multiple or Customer's Trade Name |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Powder Free Green Latex Surgical Gloves, Sterile with Aloe
Vera and Protein Content Labeling Claim (50 micrograms or
less) |
| Common Name: | Surgical Gloves |
| Classification Name: | Surgeon's Gloves (per 21 CFR 878.4460) |
4.0 Identification of The Legally Marketed Device:
Class I Powder Free natural rubber latex Surgeon's gloves, 79KGO, that meets all
the requirements of ASTM standard D 3577 - 01a22 Type 1 and FDA 21 CFR 800.20.
5.0 Description of The Device:
The Powder Free Green Latex Surgical Gloves, Sterile with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less) meets all the requirements of ASTM standard D 3577-01a"2 and FDA 21 CFR 800.20.
1
Image /page/1/Picture/9 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 "147817 V".
K02242
Intended Use of the Device: 6.0
The Powder Free Green Latex Surgical Gloves, Sterile with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less) are made of natural 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.
7.0 Summary of The Technological Characteristics of The Device:
The Powder Free Green Latex Surgical Gloves, Sterile with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less) 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 |
| 2 mg/glove maximum | ||
| Protein Level | ASTM D 5712 - 95 |