(54 days)
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No
The summary describes a surgical glove and its physical properties and performance against ASTM standards. There is no mention of AI or ML.
No
The device, a surgical glove, is intended to prevent contamination and protect wounds, not to treat or cure a disease or condition.
No
The device is a surgical glove, intended to prevent contamination between healthcare personnel and the patient. It does not perform any diagnostic function.
No
The device is a surgical glove, which is a physical hardware product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the glove is for preventing contamination between healthcare personnel and the patient's body, fluids, waste, or environment, and to protect a surgical wound from contamination. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the material (synthetic rubber latex) and compliance with standards related to physical properties and safety for use as a glove.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing information for diagnosis.
- Focus on Physical Barrier: The performance metrics listed (dimensions, physical properties, freedom from pinholes, powder-free, biocompatibility) are all related to the glove's function as a physical barrier and its safety for contact with skin.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This surgical glove does not perform any such function.
N/A
Intended Use / Indications for Use
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 Green Neoprene Surgical Glove, Sterile with Aloe Vera meets all the requirements of ASTM standard D 3577 - 01a22 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 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.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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 the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in a stylized font inside of a black oval shape. To the right of the logo is the text "WRP Asia Pacific Sdn Bhd" in a bold, sans-serif font, and below that is the number "147817 V".
KO22444
SEP 1 7 2002
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 |
22 JUL LUUZ 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 Neoprene Surgical Glove, Sterile with
Aloe Vera. |
| 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 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 Green Neoprene Surgical Glove, Sterile with Aloe Vera meets all the requirements of ASTM standard D 3577 - 01a22 and FDA 21 CFR 800.20.
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Vollir Dartner In Dra
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Image /page/1/Picture/1 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, black shape. To the right of the logo is the company name, "WRP Asia Pacific Sdn Bhd," also in a bold, sans-serif font.
6.0 Intended Use of the Device:
The Powder Free Green Neoprene Surgical Glove, Sterile with Aloe Vera 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.
7.0 Summary of The Technological Characteristics of The Device:
The Powder Free Green Neoprene Surgical Gloves, Sterile with Aloe Vera 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