(86 days)
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No
The summary describes a standard surgical glove and makes no mention of AI or ML technology.
No
The device is a surgical glove intended to protect a surgical wound from contamination, which is a protective barrier function, not a therapeutic treatment.
No
Explanation: The device is a surgeon's glove, intended to protect a surgical wound from contamination, which is a protective function, not a diagnostic one. It does not identify a condition, disease, or medical problem.
No
The device description clearly states it is a physical glove made of synthetic rubber latex, and the performance studies focus on physical properties and biocompatibility, not software functionality.
No, 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 physical barrier function, 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 (material, sterility, dimensions, etc.). There is no mention of analyzing biological samples or providing diagnostic information.
- 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 specific substances (analytes)
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition.
This device is clearly a medical device used for protection and barrier purposes in a surgical setting.
N/A
Intended Use / Indications for Use
The Powder Free, Polymer Coated Polyisoprene Surgical Glove, Sterile, 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, Polymer Coated Polyisoprene Surgical Glove, Sterile, meets all the requirements of ASTM standard D 3577 - 01a52 and FDA 21 CFR 800.20.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hand
Indicated Patient Age Range
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Intended User / Care Setting
healthcare personnel, operating room personnel and similar personnel
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile, are summarized with the following technological characteristics compared to ASTM or equivalent standards.
CHARACTERISTICS - STANDARDS - DEVICE PERFORMANCE
Dimensions - ASTM D 3577 - 01aF2 - Meets
Physical Properties - ASTM D 3577 - 01aF2 - Meets
Freedom from pinholes - ASTM D 3577 - 01aF2 FDA 21 CFR 800.20 - Meets
Powder-Free - ASTM D 6124 - 01 - Meets
§ 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 contains the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in a bold, sans-serif font, enclosed within a rounded shape. To the right of the logo is the full name of the company, "WRP Asia Pacific Sdn Bhd", also in a bold, sans-serif font. Below the company name is the number "147817 V".
DEC 1 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 1485 |
Date of Summary Prepared: 16 SEP 2003
Contact Person: 2.0
| Name: | Mr. Terence Lim |
|---|---|
| Phone No.: | +60 3 8706 1486 |
| Fax No.: | +60 3 8706 1485 |
3.0 Name of the device:
| Trade Name: | 1. Profeel, and
2. Multiple or Customer's Trade Name |
|----------------------|---------------------------------------------------------------------|
| Device Name: | Powder Free, Polymer Coated Polyisoprene Surgical Glove,
Sterile |
| 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 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, Polymer Coated Polyisoprene Surgical Glove, Sterile, meets all the requirements of ASTM standard D 3577 - 01a52 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 stylized font, with the words "WRP Asia Pacific Sdn Bhd" to the right of the letters. Below the company name is the number 147817V.
Intended Use of the Device: 6.0
The Powder Free, Polymer Coated Polyisoprene Surgical Glove, Sterile, 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, Polymer Coated Polyisoprene Surgical Gloves, Sterile, are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE
PERFORMANCE |
|-----------------------|------------------------------------------|-----------------------------------------|
| Dimensions | ASTM D 3577 - 01aF2 | Meets |
| Physical Properties | ASTM D 3577 - 01aF2 | Meets |
| Freedom from pinholes | ASTM D 3577 - 01aF2
FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 - 01 | Meets