(88 days)
No
The device description and performance studies focus on material properties, physical dimensions, and radiation attenuation, with no mention of AI or ML.
No
The device is a surgical glove designed for protection against contamination and radiation, not for treating or diagnosing a disease or condition in a patient.
No.
The device is a surgical glove designed to protect against contamination and attenuate radiation, not to diagnose medical conditions.
No
The device is a physical surgical glove made of polyisoprene, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect a surgical wound from contamination and reduce radiation exposure to the operator's hand. This is a protective barrier and radiation shielding function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description focuses on the physical properties of the glove (material, thickness, radiation attenuation) and its function as a barrier and shield. There is no mention of analyzing biological samples or providing diagnostic information.
- 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 biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition
The device is clearly described as a medical device intended for personal protection and radiation attenuation during surgical procedures.
N/A
Intended Use / Indications for Use
The polyisoprene powder free, black colour surgical gloves are radiation attenuating and intended to be worn by operating room personal to protect a surgical wound from contamination
Product codes (comma separated list FDA assigned to the subject device)
KGO, OPH
Device Description
The Polyisoprene Powder Free Black Color Radiation Attenuating Surgical Glove is a disposable sterile powder-free medical device made of polyisoprene that is intended to be worn by operating room personnel to protect a surgical wound from contamination. The glove contains radiation-attenuating particles to reduce the exposure from harmful ionizing scattered or secondary radiation on the operator's hand during fluoroscopic procedures. The glove is proposed in two (2) options. The Model 2 are made with exactly the same material and composition and differ only by their thicknesses and therefore their attenuation properties.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personal / surgical settings
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 underwent non-clinical performance testing. Key tests and results include:
- ASTM D5151: Freedom from holes, AQL=0.65 (PASS, acceptable criteria AQL 1.5)
- ASTM D3577 (Physical Dimensions):
- Length: All sizes ≥285mm (range:298-301mm) (PASS, criteria 6 to 9 ≥265mm & ≥285mm)
- Width: PASS for all sizes (e.g., size 6.5: 83-84mm, criteria 76 ± 6mm)
- Thickness:
- Model 1: Finger: 0.27-0.29mm, Palm: 0.24-0.25mm, Cuff: 0.23-0.24mm (PASS, criteria Min. 0.1mm)
- Model 2: Finger: 0.33-0.39mm, Palm: 0.33-0.35mm, Cuff: 0.31-0.33mm (PASS, criteria Min. 0.1mm)
- ASTM D3577 (Physical Properties):
- Tensile Strength: 18.7-19.6MPa (Before accelerated aging), 18.2-18.5MPa (After accelerated aging) (PASS, criteria 17 MPa min before, 12 MPa min after)
- Strength at 500%: 4.1-4.9MPa (PASS, criteria 7.0 MPa max)
- Ultimate Elongation: 700-720% (Before aging), 620-645% (After aging) (PASS, criteria 650 % min before, 490 % min after)
- ASTM D6124: Residual powder 0.05-0.18mg/glove (PASS, criteria
§ 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).
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September 29, 2023
Ineo Tech Sdn Bhd Pierre Hoerner Company Director PT5825, Jalan Cassia Selatan 3/11 Taman Perindustrian Batu Kawan Bandar Kassia, Penang 14110 Malaysia
Re: K231973
Trade/Device Name: PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I. reserved Product Code: KGO, OPH Dated: June 25, 2023 Received: July 3, 2023
Dear Pierre Hoerner:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231973
Device Name
Polyisoprene Powder Free Black Colour Radiation Attenuating Surgical Glove Model 1: Min. 0.21mm (thickness) Model 2: Min. 0.29mm (thickness)
Indications for Use (Describe)
The polyisoprene powder free, black colour surgical gloves are radiation attenuating and intended to be worn by operating room personal to protect a surgical wound from contamination
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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K231973: 510(k) SUMMARY
[per 21 CFR 807.92]
1. Submitter Information
| Name:
Address: | Ineo Tech Sdn. Bhd.
PT5825, Jalan Cassia Selatan 3/11 Taman Perindustrian
Batu Kawan, 14110, Bandar Cassia, Penang, Malaysia |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Phone: | +33 (6) 70 21 95 45 |
| E-Mail: | pierre@ineotech-my.com |
| Contact Name: | Dr Pierre Hoerner, Ph.D |
| Date of summary: | 27 Sept, 2023 |
2. Device Identification
| Trade name: | Polyisoprene Powder Free Black Color Radiation Attenuating
Surgical Gloves |
|----------------------|-------------------------------------------------------------------------------|
| Classification name: | Surgeon's glove |
| Product Code: | KGO (primary code); OPH |
| Regulation number: | 21 CFR 878.4460 |
| Device Class: | Class I (general controls) |
| Assigned 510k number | K231973 |
3. Identification of Predicate Devices
- . 510(k) number K192933 by Emerson & Co. S.r.1 is identified as the primary predicate device
- 510(k) number K022873 is considered as reference device to support specific testing or . device features.
4. Device Description
The Polyisoprene Powder Free Black Color Radiation Attenuating Surgical Glove is a disposable sterile powder-free medical device made of polyisoprene that is intended to be
4
worn by operating room personnel to protect a surgical wound from contamination. The glove contains radiation-attenuating particles to reduce the exposure from harmful ionizing scattered or secondary radiation on the operator's hand during fluoroscopic procedures. The glove is proposed in two (2) options. The Model 2 are made with exactly the same material and composition and differ only by their thicknesses and therefore their attenuation properties.
ട. Indications for Use
The Polyisoprene Powder Free Black Color Surgical Gloves are radiation attenuating and intended to be worn by operating room personal to protect a surgical wound from contamination.
Primary Subject Device Reference Device Comparison Characteristic Predicate Device 510(k) number K231973 K192933 K022873 Regulation No. 21 CFR 878.4460 21 CFR 21 CFR 878.4460 Same regulation 878.4460 number KGO Product Code KGO (primary) KGO Same product code OPH Device Class Class I Class I Class I Same device class Device type Powder-free Powder-free Powder-free sterile surgical Same indicated use sterile surgical sterile surgical glove glove glove
6. Comparison to Predicate Devices
5
| Indications for use statement | The polyisoprene powder free, black color surgical gloves are radiation attenuating and intended to be worn by operating room personnel to protect a surgical wound from contamination. | The polyisoprene powder free, black color surgical gloves are radiation attenuating and intended to be worn by operating room personnel to protect a surgical wound from contamination | A powder-free surgeon's glove is a device made of synthetic latex that may bear a trace amount of glove powder and is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. The radiation attenuating surgical glove is intended to be used during medical procedures where hands are necessarily exposed to radiation in order to offer some degree of protection to the hand from radiation. This includes surgical procedures that require the use of fluoroscopy or radiography | Similar |
|---|---|---|---|---|
| Color | Black | Black | Black | Same color |
| Size Range | 6 to 9 | 6 to 9 | 6 to 9 | Same size range |
| Use limit of the device | Single use | Single use | Single use | Same use limit |
| Technology | Latex Dipping & Sulphur vulcanization | Latex Dipping & Sulphur vulcanization | Latex Dipping & Sulphur vulcanization | Same dipping and vulcanization technology. |
| Elastomer | Non Natural Rubber Latex (PolyIsoprene) | Non Natural Rubber Latex (PolyIsoprene)) | Non Natural Rubber Latex (PolyChloroprene) | All gloves are made with Non Natural Rubber Latex elastomer. |
| RadiationAttenuation Material | (Tungsten based composition) | (Tungsten based composition) | (Tungsten based composition) | All gloves are made without Lead and contain tungsten as Radiation-Attenuation Material composition |
| Standards met | ASTM D3577 | |||
| ASTM D5151 | ||||
| ASTM D6124 | ||||
| ASTM D7866 | ASTM D3577 | |||
| ASTM D5151 | ||||
| ASTM D6124 | ||||
| ASTMD7866 | ASTM D3577 | |||
| ASTM D5151 | ||||
| ASTM D6124 | ||||
| ASTM D7866 | Same performance standards met |
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| Sterilization | Sterile (SAL 106). Radiation. | Sterile (SAL 106). Ethylene Oxide | Sterile (SAL 10-6). Radiation | Sterilization process is Radiation or Ethylene Oxide, SAL 10-6 |
|---|---|---|---|---|
| Biocompatibilty | ||||
| See Table below | Meets requirements | Meets requirements | Meets requirements | All met current requirements |
7. Summary of Non-Clinical Performance Testing
The Polyisoprene Powder Free Black Color Radiation Attenuating Surgical Glove possesses the following technological characteristics:
| Test Method | Test Purpose | Acceptable criteria | Results |
|---|---|---|---|
| ASTM D5151 | - Freedom from holes | Criteria: | |
| AQL 1.5 | PASS | ||
| AQL=0.65 | |||
| ASTM D3577 | Physical Dimensions |
- Length | Criteria:
Size 6 to 9 ≥265mm
Size 6 to 9 ≥285mm | PASS
All sizes ≥285mm
(range:298-301mm) |
| | - Width | Criteria:
size 6.0: 76 $±$ 6mm
size 6.5: 83 $±$ 6mm
size 7: 89 $±$ 6mm
size 7.5: 95 $±$ 6mm
size 8: 102 $±$ 6mm
size 8.5: 108 $±$ 6mm
size 9: 114 $±$ 6mm | PASS
83-84mm (size 6.5)
90-91mm (size 7)
96-97mm (size 7.5)
106-107mm (size 8)
110-113mm (size 8.5)
112-115mm (size 9) |
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| Test Method | Test Purpose | Acceptable criteria | Results |
|---|---|---|---|
| - Thickness | Criteria: | ||
| Min. 0.1mm | PASS | ||
| Model 1: | |||
| Finger: 0.27-0.29mm | |||
| Palm: 0.24-0.25mm | |||
| Cuff: 0.23-0.24mm |
Model 2:
Finger: 0.33-0.39mm
Palm: 0.33-0.35mm
Cuff: 0.31-0.33mm |
| ASTM D3577 | Physical Properties
- Tensile Strength | Criteria:
- Before accelerated aging:
17 MPa min - After accelerated aging:
12 MPa min | PASS
18.7-19.6MPa
18.2-18.5MPa |
| | - Strength at 500% | Criteria
7.0 MPa max | PASS
4.1-4.9MPa |
| | - Ultimate Elongation | Criteria:
- Before aging: 650 % min
- After aging: 490 % min | PASS
700-720%
620-645% |
| ASTM D6124 | - Residual powder | Criteria: