(114 days)
Not Found
No
The device is a surgical glove and the description focuses on material properties and equivalence to a predicate device, with no mention of AI or ML.
No.
The device (surgical glove) is intended to protect a surgical wound from contamination, acting as a barrier rather than directly treating or mitigating a disease or condition.
No
The device is a surgical glove, intended to protect a surgical wound from contamination, which is a protective function, not a diagnostic one.
No
The device is a surgical glove, which is a physical hardware product made of latex, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn by surgeons and operating room personnel to protect a surgical wound from contamination. This is a barrier function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description focuses on the physical characteristics of the glove and its equivalence to a previously cleared surgical glove.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly described as a surgical glove, which falls under the category of medical devices used for protection and barrier purposes in a surgical setting.
N/A
Intended Use / Indications for Use
The surgical 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 Polymer Coated Brown Latex Surgical Gloves, Sterile with Aloe Vera and with Protein Content Labeling Claim is equivalent to the existing model, i.e. Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) Contains 50 Micrograms or Less of Total Water Extractable Protein per gram which had submitted and cleared under 510(k) number K021784.
The difference in this submission is: With Aloe Vera coated on surgical gloves.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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 Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile with Aloe Vera and with Protein Content Labeling Claim are summarized with the following technological characteristics compared to ASTM or equivalent standards:
- Dimensions: Meets ASTM D 3577 - 06
- Physical Properties: Meets ASTM D 3577 - 06
- Freedom from pinholes: Meets ASTM D 3577 - 06, FDA 21 CFR 800.20
- Powder Residual: 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 shows a logo with the letters "VWRP" in a stylized font. The "V" is large and bold, with a design that suggests movement or flow. The letters "WRP" are smaller and placed to the right of the "V", creating a sense of balance in the logo. The logo is in black and white.
SPECIAL 510(k) SUMMARY
JUN 2 7 2007
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:
28 FEB 2007
2.0 Contact Person:
| Name: | Mr. Kirk Penner |
|---|---|
| Phone No.: | +60 3 8706 1486 Ext. 148 |
| Fax No.: | +60 3 8706 1557 |
3.0 Device Identification:
| Trade Name: | 1) Eudermic, and
2) Multiple or Customers' Trade Name |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Powder Free Polymer Coated Brown Latex Surgical Gloves,
Sterile, Coated with Aloe Vera and with 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 - 06 Type 1 and FDA 21 CFR 800.20.
5.0 Description of the Device:
The Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile with Aloe Vera and with Protein Content Labeling Claim is equivalent to the existing model, i.e. Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) Contains 50 Micrograms or Less of Total Water Extractable Protein per gram which had submitted and cleared under 510(k) number K021784.
1
Image /page/1/Picture/0 description: The image shows a logo with the letters "WRP" in bold, black font. To the left of the letters is a stylized graphic that resembles a "V" shape, also in black. The graphic is made up of two thick, curved lines that converge at the bottom, creating a sense of movement or flow. The overall design is simple, bold, and modern.
The difference in this submission is:
- With Aloe Vera coated on surgical gloves. a)
The modification of device 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 Brown Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim meets all the requirements of ASTM standard D 3577 - 06 and FDA 21 CFR 800.20.
6.0 Intended Use of the Device:
The Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile with Aloe Vera and with Protein Content Labeling Claim are made of natural rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.
7.0 Summary of Technological Characteristics for the Modified Device:
The Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile with Aloe Vera and with Protein Content Labeling Claim are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE
PERFORMANCE |
|-----------------------|---------------------------------------|-----------------------------------------|
| Dimensions | ASTM D 3577 - 06 | Meets |
| Physical Properties | ASTM D 3577 - 06 | Meets |
| Freedom from pinholes | ASTM D 3577 - 06
FDA 21 CFR 800.20 | Meets |
| Powder Residual | ASTM D 6124 - 06 | Meets