(23 days)
Not Found
Not Found
No
The summary describes a standard surgical glove and contains no mention of AI or ML technology.
No
The device is a surgical glove, intended to protect a surgical wound from contamination, not to treat or cure a disease or condition.
No
The device, a surgeon's glove, is intended to protect a surgical wound from contamination, which is a protective function, not a diagnostic one.
No
The device is a physical glove made of natural rubber latex, not software. The description focuses on physical properties and performance standards for gloves.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect a surgical wound from contamination by being worn by surgeons and operating room personnel. This is a barrier function for infection control, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical properties and standards met by the glove (ASTM, FDA regulations for gloves).
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. This surgical glove does not fit that description.
N/A
Intended Use / Indications for Use
The Protein Free Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) is 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 (comma separated list FDA assigned to the subject device)
KGO
Device Description
The Powder Free Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) meets all the requirements of ASTM standard D 3577 - 00 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.
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 3577 - 00 | Meets |
| Physical Properties | ASTM D 3577 - 00 | Meets |
| Freedom from pinholes | ASTM D 3577 - 00 FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 - 00 | 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
Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA
1 2001 AUG
WRP Asia Pacific Sdn Bhd
510(k) SUMMARY
Submitter: 1.0
| Name:
Address: | WRP Asia Pacific Sdn Bhd
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 |
012135
0 3 JUL 2001 Date of Summary Prepared:
Contact Person: 2.0
| Name: | Mr. Yue Wah, CHOW |
|---|---|
| Phone No.: | +60 3 8706 1486 |
| Fax No.: | +60 3 8706 1485 |
Name of the device: 3.0
| Trade Name: | 1. Profeel |
|---|---|
| 2. Multiple or Customer's Trade Name | |
| Device Name: | Powder Free Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) |
| 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 natural rubber latex Surgeon's gloves, 79KGO, that meets all
ed CER 800 2007 100 100 100 000 100 000 EDA 21 CER 800 20 Class I Powder Free natural Tuboci Tatex Cargood ogen of your and FDA 21 CFR 800.20.
the requirements of ASTM standard D 3577 -- 00 Type 1 and FDA 21 CFR 800.20.
Description of The Device: 5.0
The Powder Free Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim)
Proveder Free Brown Career Steel D. 2677 - 00 and EDA 21 CFR The Powder Free Brown Latex Bargiour Cloves, Brond (
meets all the requirements of ASTM standard D 3577 - 00 and FDA 21 CFR 800.20.
) 4 7 8 1 7 V
TEL +60-3-8706 1486 FAX +60-3-8706 1485 EML cyw_wrp@wrpworld.com URL www.wrpworld.com
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, stylized font, followed by the words "WRP Asia Pacific Sdn Bhd" in a smaller, but still bold, font. Below the company name is the number "147817 V".
6.0 Intended Use of the Device:
The Protein Free Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) is 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.
Summary of The Technological Characteristics of The Device: 7.0
The Powder Free Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE
PERFORMANCE |
|-----------------------|---------------------------------------|-----------------------------------------|
| Dimensions | ASTM D 3577 - 00 | Meets |
| Physical Properties | ASTM D 3577 - 00 | Meets |
| Freedom from pinholes | ASTM D 3577 - 00
FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 - 00 | Meets
2 mg/glove maximum |
| Protein Level | ASTM D 5712 - 95 |