(259 days)
The Skybreeze Zero Nitrile Powder-Free Exam Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs: Cyclophosphamide (20.0 mg/ml), Doxorubicin HCl (2.0 mg/ml), Etoposide (20.0 mg/ml), 5-Fluorouracil (50.0 mg/ml), Paclitaxel (Taxol) (6.0 mg/ml), Cisplatin (1.0 mg/ml), Dacarbazine (10.0 mg/ml), Ifosfamide (50.0 mg/ml), Mitoxantrone (2.0 mg/ml), Vincristine sulfate (1.0 mg/ml), Carmustine (3.3 mg/ml), ThioTEPA (10.0 mg.ml). Warning: Not for Use with: Carmustine, ThioTEPA.
The SkyBreeze Zero Nitrile Powder-Free Exam Gloves, Tested for Use with Chemotherapy Drugs are disposable, blue-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves packed in a cardboard dispenser box.
The provided text is related to the 510(k) premarket notification for "SkyBreeze Zero Nitrile Powder-Free Exam Gloves, Tested for Use with Chemotherapy Drugs." This document outlines the safety and performance characteristics of medical exam gloves, not artificial intelligence (AI) software. As such, information regarding AI-specific criteria like multi-reader multi-case (MRMC) studies, sample sizes for AI training sets, or the number of experts for AI ground truth establishment is not present.
However, I can extract information related to the acceptance criteria and studies for the medical exam gloves as described in the document.
1. A table of acceptance criteria and the reported device performance:
| Standard / Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ASTM D6978-05: Resistance to Permeation by Chemotherapy Drugs | No breakthrough for specified drugs for a certain duration (implicitly, as good as or better than predicate). | - No breakthrough up to 240 minutes for: Cyclophosphamide (20.0 mg/ml), Doxorubicin HCl (2.0 mg/ml), Etoposide (20.0 mg/ml), 5-Fluorouracil (50.0 mg/ml), Paclitaxel (Taxol) (6.0 mg/ml), Cisplatin (1.0 mg/ml), Dacarbazine (10.0 mg/ml), Ifosfamide (50.0 mg/ml), Mitoxantrone (2.0 mg/ml), Vincristine sulfate (1.0 mg/ml). - Breakthrough detected at: Carmustine (3.3 mg/ml) - 18.6 minutes, ThioTEPA (10.0 mg/ml) - 48.3 minutes. Result: Meets acceptance criteria for 10 drugs. |
| ASTM D5151-06: Detection of Holes in Medical Gloves | Meets 2.5% AQL requirement for leakage. | Testing of the subject device shows it meets the 2.5% AQL requirement in the standards for leakage. The device meets the acceptance criteria of the standard. |
| ASTM D6124-06: Residual Powder on Medical Gloves | < 2 mg maximum powder per glove. | Residual powder on the subject device is an average of 0.4 mg/glove, which is within the powder-free limit of < 2 mg maximum powder per glove, and meets the acceptance criteria for powder-free. |
| ASTM D6319-10: Nitrile Examination Gloves for Medical Applications | Physical dimensions within limits; tensile strength and elongation meet requirements. | The physical dimensions of the subject device are within the limits of the standard. Physical properties: Average tensile strength before aging of 26.17 MPa and after aging of 34.37 MPa. Elongation of 580% before aging and 554% after aging. (These meet the requirements of the standard, though specific pass/fail values are not explicitly stated here for comparison). |
| ISO 10993-11:2017: Tests for Systemic Toxicity | Non-toxic. | Based on ISO 10993 – 11 (2017), the test article was considered non-toxic. |
| ISO 10993-10:2010: Tests for Irritation and Skin Sensitization | Not a primary skin irritant; not a contact sensitizer. | Based on ISO 10993 – 10 (2010): Under the conditions of the study, not a primary skin irritant; under conditions of the study, not a contact sensitizer. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document does not explicitly state the exact sample sizes (number of gloves or individual tests) for each specific test (e.g., how many gloves were tested for chemotherapy permeation, holes, etc.). However, it refers to industry standards (ASTM, ISO) which define appropriate sample sizes for such tests.
- Data Provenance: The studies were conducted by the manufacturer, O & M Halyard, Inc., to evaluate their product. The country of origin of the data is not specified, but the submission is to the U.S. FDA, implying compliance with U.S. regulatory standards. The studies are prospective in nature, as they are part of the premarket notification process for a new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not applicable. The product is a medical exam glove, and the "ground truth" for its performance is established through standardized laboratory testing against physical, chemical, and biological properties, not through expert human interpretation of data like in an AI study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable as the studies involve laboratory testing and not human interpretation or adjudication.
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:
This is not applicable since the document refers to a medical device (exam gloves), not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the device's performance is established by objective, standardized laboratory test methods and their defined pass/fail criteria. For example:
- Chemotherapy Permeation: Measured breakthrough time of specific chemicals using analytical methods.
- Hole Detection: Visual inspection or water leak test methods defined in ASTM D5151-06.
- Residual Powder: Gravimetric analysis as per ASTM D6124-06.
- Physical Properties: Mechanical testing (tensile strength, elongation) as per ASTM D6319-10.
- Biocompatibility: In vitro or in vivo tests for toxicity, irritation, and sensitization as per ISO 10993 standards.
8. The sample size for the training set:
This is not applicable as the document does not describe an AI device with a training set.
9. How the ground truth for the training set was established:
This is not applicable as the document does not describe an AI device with a training set.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 26, 2019
O & M Halyard, Inc. Angela Bunn Director Regulatory Affairs 5405 Windward Parkway Alpharetta, Georgia 30004
Re: K182851
Trade/Device Name: SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: May 23, 2019 Received: May 24, 2019
Dear Angela Bunn:
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 mediation-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.
For Elizabeth Claverie-Williams, M.S. Assistant Director THT4B2: Disinfection, Reprocessing and Personal Protection Acting Assistant Director. THT4B1: Sterility Devices 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) K182851
Device Name
SkyBreeze Zero Nitrile Powder-Free Exam Gloves, Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
The Skybreeze Zero Nitrile Powder-Free Exam Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs:
| Tested Chemotherapy Drugs and Concentration | Average Breakthrough Detection Time (Minutes) |
|---|---|
| • Cyclophosphamide (20.0 mg/ml) | No breakthrough up to 240 minutes |
| • Doxorubicin HCl (2.0 mg/ml) | No breakthrough up to 240 minutes |
| • Etoposide (20.0 mg/ml) | No breakthrough up to 240 minutes |
| • 5-Fluorouracil (50.0 mg/ml) | No breakthrough up to 240 minutes |
| • Paclitaxel (Taxol) (6.0 mg/ml) | No breakthrough up to 240 minutes |
| • Cisplatin (1.0 mg/ml) | No breakthrough up to 240 minutes |
| • Dacarbazine (10.0 mg/ml) | No breakthrough up to 240 minutes |
| • Ifosfamide (50.0 mg/ml) | No breakthrough up to 240 minutes |
| • Mitoxantrone (2.0 mg/ml) | No breakthrough up to 240 minutes |
| • Vincristine sulfate (1.0 mg/ml) | No breakthrough up to 240 minutes |
| • Carmustine (3.3 mg/ml) | No breakthrough up to 18.6 minutes |
| • ThioTEPA (10.0 mg.ml) | No breakthrough up to 48.3 minutes |
| Warning: Not for Use with: Carmustine, ThioTEPA |
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Date Summarywas Prepared | June 25, 2019 |
|---|---|
| 510(k) Submitter | O & M Halyard, Inc.5405 Windward ParkwayAlpharetta, GA 20004 |
| Primary Contact forthis 510(k) Submission | Angela L. Bunn, Director Regulatory AffairsO & M Halyard, Inc.5405 Windward Parkway, Alpharetta, GA 30004 US(470) 448-5158 [voice]angela.bunn@hyh.com |
| Device Trade Name | SkyBreeze Zero Nitrile Powder-Free Exam Gloves, Tested for Usewith Chemotherapy Drugs |
| Device Common Name | Medical Exam Gloves |
| Device Product Codeand Classification Name | LZA, LZCClass I, 21 CFR §880.6250Patient Examination Glove |
| Predicate Device | K180646Halyard Lavender Nitrile Powder-Free Exam Gloves Tested for Usewith Chemotherapy Drugs |
| Subject Device Description | The SkyBreeze Zero Nitrile Powder-Free Exam Gloves, Tested forUse with Chemotherapy Drugs are disposable, blue-colored,chlorinated, nitrile, powder-free, textured fingertip, ambidextrous,non-sterile patient examination gloves packed in a cardboarddispenser box. The Device follows consensus standards:· ASTM D5151-06 Standard Test Method for Detection of Holes inMedical Gloves |
| · ASTM D6319-10 Standard Specification for Nitrile ExaminationGloves for Medical Applications | |
| · ASTM D6124-06 Standard Test Method for Residual Powder onMedical Gloves | |
| · ASTM D6978-05 Standard Practice for Assessment of Resistanceof Medical Gloves to Permeation by Chemotherapy Drugs | |
| · ISO 10993-11:2017, Biological evaluation of medical devices -Part 11: Tests for Systemic Toxicity | |
| · ISO 10993-10: 2010: Biological evaluation of medical devices -Part 10: Tests for Irritation and Skin Sensitization | |
| Indications for Use | The Skybreeze Zero Nitrile Powder-Free Exam Glove is a disposable deviceintended for medical purposes that is worn on the examiner's hand to preventcontamination between patient and examiner. These gloves were tested for usewith the following chemotherapy drugs:Cyclophosphamide (20.0 mg/ml) No breakthrough up to 240 minutes Doxorubicin HCI (2.0 mg/ml) No breakthrough up to 240 minutes Etoposide (20.0 mg/ml) No breakthrough up to 240 minutes 5-Fluorouracil (50.0 mg/ml) No breakthrough up to 240 minutes Paclitaxel (Taxol) (6.0 mg/ml) No breakthrough up to 240 minutes Cisplatin (1.0 mg/ml) No breakthrough up to 240 minutes Dacarbazine (10.0 mg/ml) No breakthrough up to 240 minutes Ifosfamide (50.0 mg/ml) No breakthrough up to 240 minutes Mitoxantrone (2.0 mg/ml) No breakthrough up to 240 minutes Vincristine sulfate (1.0 mg/ml) No breakthrough up to 240 minutes Carmustine (3.3 mg/ml) No breakthrough up to 18.6 minutes ThioTEPA (10.0 mg.ml) No breakthrough up to 48.3 minutes Warning: Not for Use with: Carmustine, ThioTEPA |
| Summary of comparison oftechnological characteristics | Both the subject device and the predicate device are powder-free non-sterilenitrile exam gloves tested for resistance to permeation by chemotherapydrugs. |
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| Technological Characteristics Comparison Table | |||
|---|---|---|---|
| Subject Device | Predicate Device K180646 | Comparison | |
| FDA Product Code | LZC, LZA | LZC, LZA | Same |
| FDA Classification | Class I | Class I | Same |
| Regulation Number | 880.6250 | 880.6250 | Same |
| Common Name | Medical Exam Glove | Medical Exam Glove | Same |
| Device Trade Name | SkyBreeze Zero Nitrile Powder-Free Exam Gloves Tested forUse with Chemotherapy Drugs | Halyard Lavender Nitrile Powder-Free Exam Gloves Tested for Usewith Chemotherapy Drugs | Similar |
| Intended Use | The Skybreeze Zero NitrilePowder-Free Exam Glove is adisposable device intended formedical purposes that is worn onthe examiner's hand to preventcontamination between patientand examiner. These gloveswere tested for use withchemotherapy drugs listed on thelabel. | The Halyard Lavender Nitrile-Powder-Free Exam Glove is adisposable device intended formedical purposes that is worn onthe examiner's hand to preventcontamination between patientand examiner. These gloves weretested for use with chemotherapydrugs listed on the label. | Same |
| TechnologicalCharacteristics | Blue-colored, 9.5-inch, 0.07 mmthick at palm, nitrile, powder-free,textured fingertip, ambidextrous,non- sterile patient examinationglove. | Lavender-colored, 9.5-inch, .058mm thick at palm, nitrile, powder-free, textured fingertip,ambidextrous, non- sterile patientexamination glove. | Similar |
| Sizes of gloves | Extra Small (XS)Small (S)Medium (M)Large (L)Extra Large (XL) | Extra Small (XS)Small (S)Medium (M)Large (L)Extra Large (XL) | Similardimensionswith minordifferences infingers andpalmthickness. |
| Thickness at Fingers | 0.10 mm (XS)0.10 mm (S)0.10 mm (MS)0.10 mm (L)0.10 mm (XL) | 0.078 mm (XS)0.078 (S)0.078 mm (MS)0.078 mm (L)0.078 mm (XL) | thickness. |
| Thickness at Palm | 0.07 mm (XS)0.07 mm (S)0.07 mm (M)0.07 mm (L)0.07 mm (XL) | 0.058 (XS)0.058 (S)0.058 (M)0.058 (L)0.058 (XL) | |
| Width of Palm | 70 mm (XS)80 mm (S)95 mm (M)110 mm (L)120 mm (XL) | 70 mm (XS)80 mm (S)95 mm (M)110 mm (L)120 mm (XL) | |
| Length of Palm | 240 mm (XS)240 mm (S)240 mm (M)240 mm (L)240 mm (XL) | 242 mm (XS)242 mm (S)242 mm (M)242 mm (L)242 mm (XL) | |
| Texture | Textured fingertips | Textured fingertips | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Shelf life | No Shelf life is being claimed atthis time. | No Shelf life is being claimed atthis time. | Same |
| Biocompatibility | Based ISO 10993 – 11 (2017)Biological evaluation of Medicaldevices - Test for SystemicToxicity, the test article wasconsidered non-toxic. | Based ISO 10993 – 11 (2017)Biological evaluation of Medicaldevices - Test for SystemicToxicity, the test article wasconsidered non-toxic. | Same |
| Based on ISO 10993 – 10(2010): Under the conditions ofthe study, not a primary skinirritant;Under conditions of the study,not a contact sensitizer. | Based on ISO 10993 – 10 (2010):Under the conditions of the study,not a primary skin irritant;Under conditions of the study, nota contact sensitizer. |
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| Performance Data | |||
|---|---|---|---|
| Standard | ResultsSubject Device | ResultsK180646 | Remarks |
| ASTM D6978-05Standard Practice forAssessment of Resistance ofMedical Gloves toPermeation byChemotherapy Drugs | Result: Meets acceptancecriteria for 10 drugs. | Result: Meets acceptancecriteria for 10 drugs. | Similar with differentbreakthrough timesfor Carmustine andThiotepa. |
| No breakthrough up to 240minutes: | No breakthrough up to240 minutes: | ||
| Cisplatin (1 mg/ml) Nobreakthrough up to 240minutes | Cisplatin (1 mg/ml) Nobreakthrough up to 240minutes | ||
| Cyclophosphamide (20mg/ml) No breakthrough upto 240 minutes | Cyclophosphamide (20mg/ml) No breakthroughup to 240 minutes | ||
| Dacarbazine (10 mg/ml)No breakthrough up to 240minutes | Dacarbazine (10 mg/ml)No breakthrough up to240 minutes | ||
| Doxorubicin HCL (2 mg/ml)No breakthrough up to 240minutes | Doxorubicin HCL (2mg/ml) No breakthroughup to 240 minutes | ||
| Etoposide (20 mg/ml) Nobreakthrough up to 240minutes | Etoposide (20 mg/ml) Nobreakthrough up to 240minutes | ||
| Fluorouracil (50 mg/ml) Nobreakthrough up to 240minutes | Fluorouracil (50 mg/ml)No breakthrough up to240 minutes | ||
| Ifosfamide (50 mg/ml) Nobreakthrough up to 240minutes | Ifosfamide (50 mg/ml) Nobreakthrough up to 240minutes | ||
| Mitoxantrone (2 mg/ml) Nobreakthrough up to 240minutes | Mitoxantrone (2 mg/ml)No breakthrough up to240 minutes | ||
| Paclitaxel (6 mg/ml) Nobreakthrough up to 240minutes | Paclitaxel (6 mg/ml) Nobreakthrough up to 240minutes | ||
| Vincrinstine Sulfate (1mg/ml) No breakthrough upto 240 minutes | Vincrinstine Sulfate (1mg/ml) No breakthroughup to 240 minutes | ||
| Carmustine (3.3 mg/ml)showed no signs ofbreakthrough until 18.6minutes | Carmustine (3.3 mg/ml)showed no signs ofbreakthrough until 0.3minutes | ||
| Thiotepa (10 mg/ml)showed no signs ofbreakthrough until 48.3minutes | Thiotepa (10 mg/ml)showed no signs ofbreakthrough until 30.9minutes. | ||
| ASTM D5151-06Standard Test Method forDetection of Holes in MedicalGloves | Testing of the subjectdevice shows it meets the2.5% AQL requirement inthe standards for leakage.The device meets theacceptance criteria of thestandard. | Testing of the subjectdevice shows it meets the2.5% AQL requirement inthe standards for leakage.The device meets theacceptance criteria of thestandard. | Same |
| ASTM D6124-06Standard Test Method forResidual Powder on MedicalGloves | Residual powder on thesubject device is anaverage of 0.4 mg/glovewithin the powder-free limitof < 2 mg maximumpowder per glove andmeets the acceptancecriteria for powder- free. | Residual powder on thesubject device is anaverage of 0.4 mg/glovewithin the powder-freelimit of < 2 mg maximumpowder per glove andmeets the acceptancecriteria for powder- free. | Same |
| ASTM D6319-10Standard Specification forNitrile Examination Gloves forMedical Applications | The physical dimensions ofthe subject device arewithin the limits of thestandard and the physicalproperties of the subjectdevice meet therequirements for tensilestrength with an averagebefore aging of 26.17 MPaand after aging of 34.37MPa and elongation of580% before aging and554% after aging. | The physical dimensionsof the predicate deviceare within the limits of thestandard and the physicalproperties meet therequirements for tensilestrength with an averagebefore aging of 30.56MPa and after aging of37.53 MPa and elongationof 593% before aging and533% after aging. | Similar |
| Conclusion: | The conclusions drawn from the nonclinical tests demonstrate that the proposeddevice is as safe, as effective, and performs as well as or better than the legallymarketed predicated device. |
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§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.