(71 days)
Not Found
No
The device description and performance studies focus on the physical properties and standards compliance of surgical gloves, with no mention of AI or ML.
No
Explanation: The device is described as surgical gloves primarily intended to prevent contamination, not to treat or cure a disease or condition. Its function is barrier protection for infection control.
No
The device is surgeon's gloves, which are used to prevent contamination during surgical procedures, not to diagnose medical conditions.
No
The device description clearly states it is a physical product (gloves) made from various materials and designed to comply with physical measurements, with performance studies focused on physical characteristics. There is no mention of software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Function: The description clearly states that these are surgeon's gloves worn during surgical procedures to prevent contamination. Their function is a physical barrier, not to analyze biological samples.
- Intended Use: The intended use is to prevent contamination between the user and the patient during surgery, which is a direct physical interaction, not an in vitro diagnostic test.
- Device Description: The description focuses on the physical properties and materials of the gloves, not on any diagnostic capabilities.
- Performance Studies and Metrics: The performance studies and key metrics relate to the physical integrity and properties of the gloves (size, strength, thickness, powder levels), not to the accuracy or reliability of a diagnostic test.
Therefore, based on the provided information, this device is a Class II medical device (specifically, a surgical glove) and not an IVD.
N/A
Intended Use / Indications for Use
The surgeon's gloves are sterile gloves worn by surgeons, healthcare workers or similar personnel during surgical procedures to prevent contamination between the user and the patient.
Product codes
KGO
Device Description
The device is designed to comply with the physical measurements of ASTM D 3577.
Product described as: Surgeon's Gloves or Surgical Gloves. Anatomical in shape. Hand Specific (Left or Right).
Sizes available: 6, 6½, 7, 7½, 8, 8½, 9.
Product Specification: ASTM D 3577 (91), EN 455 Part 1 & 2 (94), EN 552 (94), EN 556 (94).
Materials: Natural Rubber Latex, S, ZnO, ZDEC, ZDBC, TiO2, Styrenated Phenol, Absorbable Corn Starch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
surgeons, healthcare workers or similar personnel / Hospitals, Clinic, Ambulance, Nursing Homes
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
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Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 is a black and white drawing of a compass rose. The compass rose has four points, each pointing in a different direction. The points are decorated with a stylized letter "H". The compass rose is symmetrical and has a simple design.
510(k) Submission for Surgeon's Gloves
JAN 2 9 1:98
510(k) Summary
| Applicant | Terang Nusa Sdn Bhd |
|---|---|
| Address | Lot E4(4), Jalan 8 |
| Pengkalan Chepa II FTZ | |
| 16100 Kota Bharu | |
| Kelantan, | |
| Malaysia | |
| Tel | + 60 (9) 773 5133 |
| Fax | + 60 (9) 773 7755 |
| Contact Person | LOW, Chin Guan (Managing Director) |
| Nikolaus WEISS (QA Manager) | |
| Summary prepared by | LOW, Chin Guan |
| Date | 15 July 1997 |
1
Image /page/1/Figure/0 description: The image shows a black and white compass rose. The compass rose has eight points, each representing a cardinal direction. The compass rose is a traditional symbol used on maps and charts to indicate direction. The image is simple and clear, making it easy to understand the basic design of a compass rose.
510(k) Submission for Surgeon's Gloves
Device Name 1.
| General Name : | Surgical Glove
Surgeon's Glove |
|-----------------------|-----------------------------------------|
| Proprietary Name : | SUR-G GLOV® |
| Classification : | Surgeon's Glove
21 CFR Part 878.4460 |
| Classification Code : | 79 KGO |
Substantial Equivalence Comparison Product 2.
The device is compared to
| i) | Product | : | Triflex Surgeon's Glove |
|---|---|---|---|
| Manufactured by | : | Travenol Laboratories | |
| 510(k) | : | K832448 | |
| Classification | : | Surgeon's Glove | |
| : | 21 CFR Part 878.4460 | ||
| Quality Standard | : | ASTM D-3577 | |
| ii) | Product | : | Comfit Surgeon's Glove |
| Manufactured by | : | Wembley Rubber Products | |
| 510(k) | : | K903446 | |
| Classification | : | Surgeon's Glove | |
| : | 21 CFR Part 878.4460 | ||
| Quality Standard | : | ASTM D-3577 |
3. Intended Use of Device
The surgeon's gloves are sterile gloves worn by surgeons, healthcare workers or similar personnel during surgical procedures to prevent contamination between the user and the patient.
2
Image /page/2/Figure/0 description: The image shows a black and white drawing of a compass rose. The compass rose has eight points, with each point having a distinct shape. The drawing is simple and lacks shading or color variations.
Details of comparison data ( substantial equivalence ) 4.
| Areas of similarity | SUR-G GLOV® | TRIFLEX | COMFIT |
|---|---|---|---|
| Indications for Use | Yes | Yes | Yes |
| Design | Anatomical | Anatomical | Anatomical |
| Materials | Natural Latex | Natural Latex | Natural Latex |
| Performance | Per ASTM D3577 | Per ASTM D3577 | Per ASTM D3577 |
| Sterility | Yes | Yes | Yes |
| Biocompatibility | Yes | Yes | Yes |
| Physical properties | Per ASTM D3577 | Per ASTM D3577 | Per ASTM D3577 |
| Chemical Safety | Yes | Yes | Yes |
| Sterilization Method | Gamma Radiation | Gamma Radiation | Gamma Radiation |
| Compatibility of material | |||
| with environment | Natural Rubber | Natural Rubber | Natural Rubber |
| Usage | Hospitals, Clinic, | ||
| Ambulance | Hospitals, Clinic, | ||
| Ambulance | Hospitals, Clinic. | ||
| Ambulance | |||
| Nursing Homes | Nursing Homes | Nursing Homes | Nursing Homes |
| Standards met | ASTM D3577 | ASTM D3577 | ASTM D3577 |
| Shelf Life | 5 years | 5 years | 5 years |
| W.S. Protein |