(88 days)
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
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.
The provided text describes the acceptance criteria and results of non-clinical performance testing for a medical device, specifically Polyisoprene Powder Free Black Colour Radiation Attenuating Surgical Gloves. It does not describe a study involving AI or human readers for diagnostic purposes. Therefore, most of the requested fields related to AI performance, human reader studies, and training data are not applicable based on the provided document.
Here's a summary of the available information:
1. A table of acceptance criteria and the reported device performance:
| Test Method | Test Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM D5151 | Freedom from holes | AQL 1.5 | PASS (AQL=0.65) |
| ASTM D3577 | Physical Dimensions - Length (Size 6-9) | ≥265mm (Predicate) / ≥285mm (Manufacturer) | PASS (All sizes ≥285mm, range: 298-301mm) |
| ASTM D3577 | Physical Dimensions - Width (various sizes) | Size 6.0: 76 ± 6mmSize 6.5: 83 ± 6mmSize 7: 89 ± 6mmSize 7.5: 95 ± 6mmSize 8: 102 ± 6mmSize 8.5: 108 ± 6mmSize 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)) |
| ASTM D3577 | Physical Dimensions - Thickness | 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 (Before accelerated aging) | 17 MPa min | PASS (18.7-19.6MPa) |
| ASTM D3577 | Physical Properties - Tensile Strength (After accelerated aging) | 12 MPa min | PASS (18.2-18.5MPa) |
| ASTM D3577 | Physical Properties - Strength at 500% | 7.0 MPa max | PASS (4.1-4.9MPa) |
| ASTM D3577 | Physical Properties - Ultimate Elongation (Before aging) | 650 % min | PASS (700-720%) |
| ASTM D3577 | Physical Properties - Ultimate Elongation (After aging) | 490 % min | PASS (620-645%) |
| ASTM D6124 | Residual powder | <2mg / glove | PASS (0.05-0.18mg/glove) |
| ASTM D7866 | Attenuation Requirements (at cuff) | 60 kVp: 29%80 kVp: 22%100 kVp: 18%120 kVp: 15% | PASS (Model 1: 60kVp: 42.0-43.0%, 80kVp: 34.4-35.0%, 100kVp: 28.9-29.4%, 120kVp: 25.1-25.4%; Model 2: 60kVp: 50.5-51.3%, 80kVp: 42.0-42.7%, 100kVp: 36.2-36.7%, 120kVp: 31.2-31.6) |
| ISO 10993-10, Skin Irritation | Determine if an extract produces skin irritation | No skin irritation | PASS (Negligible skin irritation observed) |
| ISO 10993-10, Dermal Sensitization | Determine if an extract produces Dermal Sensitization | No skin sensitization | PASS (No skin sensitization produced in guinea pigs) |
| ISO 10993-11, Acute Systemic Toxicity | Determine if an extract causes systemic toxicity in vivo | Meet systemic toxicity test | PASS (Meet the requirement of acute systemic toxicity test) |
| ISO 10993-5, Cytotoxicity | In vitro cytotoxicity on extract | Comparable cytotoxicity to predicate device | PASS (Both devices exhibited slight reactivity at 50x dilution concentration) |
| ASTM D7102-22, Endotoxin | Determination of bacterial endotoxin on gloves | Endotoxin level < 20 EU/device on 3 production batches | PASS (12.9, 12.8, and 15.4 EU/device reported) |
| ISO 21582-21, Pyrogenicity | Pyrogen testing | Non pyrogenic | PASS (Non pyrogenic and meets US Pharmacopeia requirements) |
2. Sample size used for the test set and the data provenance:
- The document primarily references standards (ASTM, ISO) for testing. These standards define the sampling plans for various tests (e.g., AQL for freedom from holes).
- For the Endotoxin determination (ASTM D7102-22), it explicitly states that the test was performed on 3 production batches. No specific sample size (number of gloves) per batch is given.
- For Biocompatibility tests (ISO 10993-10, -11, -5), the tests were performed on "an extract of the product" and involved "rabbit," "guinea pigs," and "in vitro." Specific sample sizes of animals or in vitro repetitions are not provided.
- Data provenance (country of origin, retrospective/prospective): Not specified in the provided text. The submission is from Ineo Tech Sdn Bhd in Malaysia.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a medical glove requiring physical, chemical, and biological performance testing against established standards, not a diagnostic device requiring expert opinion for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. See point 3. Testing is based on objective measurements against predefined criteria in standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is defined by the acceptance criteria specified in internationally recognized standards (ASTM, ISO) for medical gloves. These standards define measurable physical, chemical, and biological properties.
8. The sample size for the training set:
- Not applicable. This is a manufactured product, not a machine learning model requiring a "training set."
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
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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 PerindustrianBatu 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 AttenuatingSurgical 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
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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
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| 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 D3577ASTM D5151ASTM D6124ASTM D7866 | ASTM D3577ASTM D5151ASTM D6124ASTMD7866 | ASTM D3577ASTM D5151ASTM D6124ASTM 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 |
|---|---|---|---|---|
| BiocompatibiltySee 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 | PASSAQL=0.65 |
| ASTM D3577 | Physical Dimensions- Length | Criteria:Size 6 to 9 ≥265mmSize 6 to 9 ≥285mm | PASSAll sizes ≥285mm(range:298-301mm) |
| - Width | Criteria:size 6.0: 76 $±$ 6mmsize 6.5: 83 $±$ 6mmsize 7: 89 $±$ 6mmsize 7.5: 95 $±$ 6mmsize 8: 102 $±$ 6mmsize 8.5: 108 $±$ 6mmsize 9: 114 $±$ 6mm | PASS83-84mm (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 | PASSModel 1:Finger: 0.27-0.29mmPalm: 0.24-0.25mmCuff: 0.23-0.24mmModel 2:Finger: 0.33-0.39mmPalm: 0.33-0.35mmCuff: 0.31-0.33mm | |
| ASTM D3577 | Physical Properties- Tensile Strength | Criteria:- Before accelerated aging:17 MPa min- After accelerated aging:12 MPa min | PASS18.7-19.6MPa18.2-18.5MPa |
| - Strength at 500% | Criteria7.0 MPa max | PASS4.1-4.9MPa | |
| - Ultimate Elongation | Criteria:- Before aging: 650 % min- After aging: 490 % min | PASS700-720%620-645% | |
| ASTM D6124 | - Residual powder | Criteria:<2mg / glove | PASS0.05-0.18mg/glove |
| Test Method | Test Purpose | Acceptable criteria | Results |
| ASTM D7866 | Attenuationrequirements(Measured in thethinnest portion of theglove, i.e cuff) | Criteria:60 kVp: 29%80 kVp:22%100 kVp:18%120 kVp:15% | PASSModel 160kVp: 42.0-43.0%80kVp: 34.4-35.0%100kVp:28.9-29.4%120kVp: 25.1-25.4%Model 2:60kVp:50.5-51.3%80kVp: 42.0-42.7%100kVp:36.2-36.7120kVp: 31.2-31.6 |
| BiocompatibilityISO 10993-10, SkinIrritation | - Determine if anextract of the productproduces skinIrritation | - No skin irritation | PASSUnder the condition of thestudy:- No skin irritation wasobserved. The skinirritation responsecategory of both polar andnon-polar extract of thetest item in rabbit isnegligible. |
| ISO 10993-10, DermalSensitization | - Determine if anextract of the productproduces DermalSensitization afterrepeated exposure | - No skin sensitization | - No skin sensitizationwas produced in guineapigs. |
| ISO 10993-11, AcuteSystemic Toxicity | - Determine if anextract of the productcauses systemictoxicity in vivo | - Meet systemic toxicitytest | - The tested glove meetsthe requirement of acutesystemic toxicity test. |
| Test Method | Test Purpose | Acceptable criteria | Results |
| ISO 10993-5,Cytotoxicity | - In vitro cytotoxicityon extract | - Comparable cytotoxicityto predicate device | - Both devices exhibited aslight reactivity at 50xdilution concentration. |
| ASTM D7102-22,Endotoxin | - Determination ofbacterial endotoxin ongloves | - Endotoxin levelaccording toASTMD7102-17 less than20 EU/device on 3production batches | - Endotoxin determinationperformed according toASTMD7102-17 showed12.9, 12.8 and 15.4 |
| ISO 21582-21,Pyrogenicity | - Pyrogen testing | - Non pyrogenic | - Extract of test itemevaluated for pyrogen testis non pyrogenic andmeets the requirements ofpyrogenicity test as perUS Pharmacopeia |
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8. Clinical Data
Clinical data is not needed for medical glove 510(k) submissions.
9. Conclusion Statement
The conclusions drawn from the nonclinical tests demonstrate that the Polyisoprene Powder Free Black Color Radiation Attenuating Surgical Glove is as safe, as effective, and performs as well as or better than the legally marketed devices identified.
§ 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).