(14 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of surgical gloves, with no mention of AI or ML.
No.
The device is a surgical glove intended to protect a surgical wound from contamination, not to provide therapy for a medical condition or disease.
No
The device is a surgical glove, which is used for protection against contamination, not for diagnosing medical conditions.
No
The device description clearly states it is a surgical glove made of synthetic latex, which is a physical hardware product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the surgical glove is intended to be worn on the hand to protect a surgical wound from contamination and prevent contamination between personnel and the patient. This is a barrier function, not a diagnostic function performed on a specimen.
- Lack of Diagnostic Information: The device description and performance studies focus on physical properties, dimensions, and freedom from defects – characteristics relevant to a barrier device, not a diagnostic test. There is no mention of analyzing biological samples or providing diagnostic results.
Therefore, based on the provided information, the surgical glove is a medical device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Powder Free Polymer Coated Green Neoprene Surgical Gloves, Sterile are 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 surgical glove is a device made of synthetic 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 Polymer Coated Green Neoprene Surgical Gloves, Sterile are made of synthetic rubber latex and are distinguished from the predicate device by a change in colour additive to green. They meet the requirements of ASTM standard D 3577 - 01a52 and FDA 21 CFR 800.20 for dimensions, physical properties, freedom from pinholes, and powder residual.
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; surgeons and/or operating room 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 device performance was summarized based on technological characteristics compared to ASTM or equivalent standards, indicating that the device "Meets" standards for Dimensions (ASTM D 3577 - 01aE2), Physical Properties (ASTM D 3577 - 01aE2), and Freedom from pinholes (ASTM D 3577 - 01aE2, FDA 21 CFR 800.20). For Powder Residual (ASTM D 6124 - 01), the device "Meets" the standard with
§ 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 a logo with the letters "WRP" in bold, white font against a black, hexagonal background. The letters are large and take up most of the space within the hexagon. The logo is simple and eye-catching, with a clear contrast between the text and the background.
SPECIAL 510(k) SUMMARY
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1.0 Submitter:
DEC 3 0 2002
| 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 |
1 3 DEC 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) | Comfit, and |
|---|---|---|
| 2) | Multiple or Customers' Trade Name | |
| Device Name: | Powder Free Polymer Coated Green Neoprene Surgical | |
| Gloves, 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.
Description of Device Modification: 5.0
The Powder Free Polymer Coated Green Neoprene Surgical Gloves, Sterile is equivalent to the existing model, i.e. Profeel Powder Free Polymer Coated Neoprene Surgical Gloves, Sterile which had submitted and cleared under 510(k) number K003019.
1
Image /page/1/Picture/0 description: The image shows a logo with the letters "WRP" in white, set against a black, hexagonal background. The letters are bold and sans-serif, filling most of the space within the hexagon. The logo has a simple, clean design, making it easily recognizable.
WRP Asia Pacific Sdn Bhd
The difference in this submission is:
- Change of colour additive used, i.e. Green a)
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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 Polymer Coated Green Neoprene Surgical Gloves, Sterile meets all the requirements of ASTM standard D 3577 -- 01a52 and FDA 21 CFR 800.20.
6.0 Intended Use of the Device:
The Powder Free Polymer Coated Green Neoprene Surgical Gloves, Sterile are 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.
7.0 Summary of Technological Characteristics for the Modified Device:
The Powder Free Polymer Coated Green Neoprene Surgical Gloves, Sterile 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 Residual | ASTM D 6124 - 01 | Meets