(47 days)
79 KGO
KGO
No
The device description and performance studies focus on the physical properties and biocompatibility of a surgical glove, with no mention of AI or ML technologies.
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 provided text describes a surgical glove, which is used for protection during medical procedures, not for diagnosing a condition.
No
The device is a physical surgical glove, not a software application. The description focuses on material properties and physical standards.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the glove is "worn by surgeon's and / or operating room personnel to protect a surgical wound from contamination." This is a barrier device used on the body during a medical procedure, not a device used to examine specimens outside the body to diagnose or monitor a condition.
- Device Description: The description focuses on the physical properties and standards related to a surgical glove (ASTM D 3577 - 00, FDA 21 CFR 800.20). These standards are for medical gloves, not IVD devices.
- 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 substances in samples
- Providing diagnostic information
- Using reagents or assays
The device described is a medical device, specifically a surgical glove, intended for barrier protection during surgery.
N/A
Intended Use / Indications for Use
The Powder Free Polymer Coated Latex Surgical Glove, Sterile with Protein Content Labeling (50 micrograms or less) is a disposable device intended for medical purposes that is worn by surgeon's and / or operating room personnel to protect a surgical wound from contamination.
Product codes
KGO
Device Description
The Powder Free Polymer Coated Latex Surgical Glove, Sterile with Protein Content Labeling (50 micrograms or less) 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
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
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
| 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 - 97 |
§ 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
510(k) Summary
Submitter: 1.0
FEB 1 3 2002
| Name | : | WRP Specialty Products Sdn. Bhd. |
|---|---|---|
| Address | : | Lot 11, Jalan 2, Kawasan Perusahaan Bandar Baru Salak |
| Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA | ||
| Phone No. | : | +60 3 8706 9788 |
| Fax No. | : | +60 3 8706 5020 |
Date of Summary Prepared : 1st August, 2001
2.0 Contact Person:
| Name: | Mr. Mohd Haizan Hussein |
|---|---|
| Phone No .: | +60 3 8706 9788 |
| Fax No .: | +60 3 8706 5020 |
3.0 Name of the device:
| Trade Name | : Powder Free Polymer Coated Latex Surgical Glove,
Sterile with Protein Content Labeling (50 micrograms or
less) |
|---------------------|------------------------------------------------------------------------------------------------------------------------|
| Common Name | : Surgeon's Gloves |
| Classification Name | : Surgeon's Gloves |
Identification of The Legally Marketed Device: 4.0
Class I natural rubber latex surgeon's glove, 79 KGO, powder free, protein content labeling. It meets all of the requirements of ASTM standard D 3577 - 00 and FDA 21 CFR 800.20.
5.0 Description of The Device:
The Powder Free Polymer Coated Latex Surgical Glove, Sterile with Protein Content Labeling (50 micrograms or less) meets all the requirements of ASTM Standard D 3577 - 00 and FDA 21 CFR 800.20.
1
6.0 Intended Use of the Device:
The Powder Free Polymer Coated Latex Surgical Glove, Sterile with Protein Content Labeling (50 micrograms or less) are disposable devices intended for medical purposes that is worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.
Summary of the Technological Characteristics of the Device: 7.0
The Powder Free Polymer Coated Latex Surgical Glove, Sterile with Protein Content Labeling (50 micrograms or less) 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 - 97 |