(133 days)
These powder-free sterile light brown colored surgeon's gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time inMinutes, 0.01 µg/cm²/minute | |
|---|---|---|
| 1. | Carmustine (BCNU) (3.3 mg/ml) | 0.20 |
| 2. | Cisplastin, (1.0 mg/ml) | >240 |
| 3. | Cyclophosphamide (20 mg/ml) | >240 |
| 4. | Doxorubicin HCl (2.0 mg/ml) | >240 |
| 5. | Etoposide (20 mg/ml) | >240 |
| 6. | Fluorouracil (50.0 mg/ml) | >240 |
| 7. | Methotrexate (25 mg/ml) | >240 |
| 8. | Paclitaxel (6.0 mg/ml) | >240 |
| 9. | Thiotepa (10.0 mg/ml) | 82.2 |
| 10. | Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that the following drug has extremely low permeation time of less than 30 minutes: Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 0.20 minute.
The proposed device is a disposable device. It is not made with natural rubber latex. Instead, the gloves are formulated using neoprene synthetic polymer and are coated with nitrile coating. The gloves are manufactured using exact same material used in the currently cleared device, Duraprene SMT gloves, that have been legally marketed by Cardinal Health under K102500. The gloves are manufactured using molds that feature anti-slip finish, independent thumb, and tapered mechanically locking cuffs to help reduce cuff roll down. They are light brown in color and are offered powder-free and sterile.
The acceptance criteria and device performance are as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard/Test/FDA Guidance) | Reported Device Performance (Results Summary) |
|---|---|---|
| Biocompatibility: Primary Skin Irritation | ISO 10993-10 | Gloves are non-irritating. (Pass) |
| Biocompatibility: Guinea Pig Maximization | ISO 10993-10 | Gloves do not display any potential for sensitization. (Pass) |
| Physical Characteristics: Dimensions | ASTM D3577 | Meet requirements |
| Physical Characteristics: Physical Properties | ASTM D3577 | Meet requirements for rubber surgical gloves |
| Freedom from Holes | 21 CFR 800.20 & ASTM D3577 | Tested in accordance with ASTM D5151 with acceptable results (Meets AQL requirements) |
| Powder Residual | ASTM D3577 tested using ASTM D6124 standard test method | Gloves meet powder level requirements for "Powder-Free" designation per ASTM D3577. Results generated values < 2mg of residual powder per glove. |
| Chemotherapy Drug Permeation | ASTM D6978 | Exceeded maximum testing time of 240 minutes for most drugs. Carmustine (BCNU) (3.3 mg/ml) showed permeation time of 0.20 minutes. Thiotepa (10 mg/ml) showed permeation time of 82.2 minutes. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test mentioned (e.g., number of gloves tested for permeation, number of animals for biocompatibility). The testing was conducted according to established international and national standards (ISO 10993-10, ASTM D3577, ASTM D6124, ASTM D6978, 21 CFR 800.20). These standards typically specify the required sample sizes for such tests to ensure statistical validity. The data provenance is not specified in terms of country of origin, but it is implied to be from testing labs adhering to these standards, likely in association with Cardinal Health for regulatory submission in the USA. The data would be prospective, as it was generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This device is a medical glove, a physical product, and the "ground truth" for its performance is established through objective laboratory testing against material and safety standards, not through expert consensus on interpretation of data like in an imaging study. Therefore, the concept of "experts used to establish ground truth" in the way it applies to diagnostic AI is not relevant here. The ground truth is defined by the technical specifications and performance limits set by the referenced ASTM and ISO standards and FDA regulations. The "experts" in this context would be the qualified laboratory personnel conducting the tests and the regulatory bodies defining these standards.
4. Adjudication Method for the Test Set
Not applicable. As noted above, performance is measured against objective standards, not through subjective human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret images or other data, and the AI's impact on their performance is being evaluated. This document pertains to a medical glove, where performance is assessed through physical and chemical testing.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance assessment was done. The device performance (e.g., physical properties, biocompatibility, chemotherapy drug permeation) was evaluated independently through laboratory testing, without a "human-in-the-loop" component in the sense of a diagnostic interpretation task. The "algorithm" here is the glove itself, and its performance is measured directly against predefined criteria.
7. The Type of Ground Truth Used
The ground truth used is based on objective measurements and predefined standards (ASTM D3577, ASTM D6978, ISO 10993-10, 21 CFR 800.20). For example:
- Physical properties: Measured values (e.g., dimensions, tensile strength) compared against specified limits in ASTM D3577.
- Freedom from holes: Determined by a water leak test (ASTM D5151) and assessed against AQL (Acceptable Quality Level) requirements as per 21 CFR 800.20 and ASTM D3577.
- Powder residual: Quantitative measurement of powder per glove (ASTM D6124) compared against the < 2.0 mg/glove requirement for "powder-free."
- Chemotherapy drug permeation: Measured breakthrough detection time of specific chemotherapy drugs compared against a standard detection limit (0.01 µg/cm²/minute) over a specified testing period (up to 240 minutes) detailed in ASTM D6978 for each drug.
- Biocompatibility: Results from established biological evaluation tests (e.g., primary skin irritation, guinea pig maximization) against criteria in ISO 10993-10.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not a software algorithm that requires a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is a physical medical device, not an AI/ML algorithm requiring a training set.
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. רכת (KI3707)
Page / of 4
APR 2 7 2012
Image /page/0/Picture/3 description: The image shows the logo for Cardinal Health. The logo consists of a stylized bird-like graphic above the company name. The company name, "CardinalHealth", is written in a bold, sans-serif font, with the first letter of each word capitalized.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES
(A summary of safety and effectiveness information in accordance with the requirements of 21 CFR
807.92)
| Applicant: | Cardinal Health1430 Waukegan RoadMcGaw Park, IL 60085 |
|---|---|
| EstablishmentRegistration Number: | 1423537 |
| Regulatory Affairs | |
| Contact: | Tatyana Bogdan, RAC |
| Telephone: | 847-887-2325 |
| Fax: | 847-887-2717 |
| E-mail: | tatyana.bogdan-curvin@cardinalhealth.com |
| Summary Prepared: | November 13, 2011 |
| Trade Name: | Sterile Neoprene Powder-Free Surgical Gloves Tested for Use withChemotherapy Drugs |
| Common Name: | Surgeon's Gloves |
| Classification Name: | Surgeon's Gloves |
| Classification Panel: | General and Plastic Surgery |
| Regulation: | 21 CFR 878.4460 |
| Product Code(s): | 79KGO |
| Legally marketeddevice(s) to whichequivalence is claimed: | 1. Duraprene SMT Sterile Polyisoprene Powder-Free Surgical Gloves,510(k) K102500, (product code 79KGO).2. Duraprene Sterile Neoprene Powder-Free Surgical Gloves, 510(k)K013302, (product code 79KGO) |
| Reason for 510(k)Submission: | Addition of new indications for use: Tested for Use with ChemotherapyDrugs |
| Device Description: | The proposed device is a disposable device. It is not made with natural rubberlatex. Instead, the gloves are formulated using neoprene synthetic polymer andare coated with nitrile coating. The gloves are manufactured using exact samematerial used in the currently cleared device, Duraprene SMT gloves, that have |
Cardinal Health, Inc.
Premarket Notification Submission -- Traditional 510(k).
б
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been legally marketed by Cardinal Health under K102500. The gloves are manufactured using molds that feature anti-slip finish, independent thumb, and tapered mechanically locking cuffs to help reduce cuff roll down. They are light brown in color and are offered powder-free and sterile.
Intended Use:
This powder-free surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time, 0.01µg/cm²/minute | |
|---|---|---|
| 1. | Carmustine (BCNU) (3.3 mg/ml) | 0.20 |
| 2. | Cisplastin, (1.0 mg/ml) | >240 |
| 3. | Cyclophosphamide (20 mg/ml) | >240 |
| 4. | Doxorubicin HCl (2.0 mg/ml) | >240 |
| 5. | Etoposide (Toposar) (20 mg/ml) | >240 |
| 6. | Fluorouracil (50 mg/ml) | >240 |
| 7. | Methotrexate (25 mg/ml) | >240 |
| 8. | Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| 9. | Thiotepa (10 mg/ml) | 82.2 |
| 10. | Vincristine sulfate (1 mg/ml) | >240 |
Please note that the following drugs have extremely low permeation time of less than 30 minutes: Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 0.20 minute.
Summary of the technological characteristics of the device compared to the predicate device:
| Characteristic | Subject DeviceSterile Neoprene Powder-Free Surgical Glovew/Chemo Claim | PredicateSterile Neoprene Powder-Free Surgical Glove(K102500) | PredicateSterile Neoprene Powder-Free Surgical Glove(K013302) |
|---|---|---|---|
| Design | Single Use | Single Use | Single Use |
| Sterile | Sterile | Sterile | |
| Powder-free | Powder-free | Powder-free | |
| Hand Specific | Hand Specific | Hand Specific | |
| Independent Thumb | Independent Thumb | Independent Thumb | |
| Beaded Cuff | Beaded Cuff | Beaded Cuff | |
| Lubricated | Lubricated | Lubricated | |
| MaterialComposition | Synthetic NeoprenePolymer coated withNitrile | Synthetic NeoprenePolymer coated withNitrile | Synthetic NeoprenePolymer coated withNitrile |
| Intended Use | Powder-Free Surgeon'sGlove | Powder-Free Surgeon'sGlove | Powder-Free Surgeon'sGlove |
Cardinal Health, Inc. Premarket Notification Submission - Traditional 510(k)
7
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| Indications for Use | Tested for Use withChemotherapy Drugs | Not Tested | Tested for Use withChemotherapy Drugs | |
|---|---|---|---|---|
| Dimensions &Physical Properties | Meets ASTM D3577 | Meets ASTM D3577 | Meets ASTM D3577 | |
| Freedom fromHoles | AQL meets 21CFR 800.20& ASTM D3577requirements | AQL meets 21CFR 800.20& ASTM D3577requirements | AQL meets 21CFR 800.20& ASTM D3577requirements | |
| Powder Residual | Meets requirements of<=2.0 mg/glove forPowder-Free designationper ASTM D3577 | Meets requirements of<=2.0 mg/glove forPowder-Free designationper ASTM D3577 | Meets requirements of<=2.0 mg/glove forPowder-Free designationper ASTM D3577 | |
| PERFORMANCE DATA | ||||
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE | ||||
| Performance Test Summary-New Device | ||||
| Characteristic | Standard/Test/FDAGuidance | Results Summary | ||
| Biocompatibility:Primary Skin Irritation | ISO 10993-10 | Gloves are non-irritating. | ||
| Guinea Pig Maximization | ISO 10993-10 | Gloves do not display any potential forsensitization. | ||
| Physical Characteristics:Dimensions | ASTM D3577 | Meet requirements | ||
| Physical Properties | ASTM D3577 | Meet requirements for rubber surgical gloves | ||
| Freedom from Holes | 21 CFR 800.20 & ASTMD3577 | Tested in accordance with ASTM D5151 withacceptable results | ||
| Powder Residual | ASTM D3577 tested usingASTM D6124 standard testmethod | Gloves meet powder level requirements for"Powder-Free" designation per ASTM D3577.Results generated values < 2mg of residualpowder per glove. | ||
| Chemotherapy DrugPermeation | ASTM D6978 | Gloves were tested using ASTM D6978. Underthe test conditions prescribed by the test, theminimum normalized breakthrough detectiontimes for each of the chemotherapy drugs testedexceeded the maximum testing time of 240minutes except for Carmustine (BCNU) (3.3mg/ml), which showed permeation time of 0.20minutes, and Thiotepa (10 mg/ml), whichshowed permeation time of 82.2 minutes. | ||
| Comparative Performance Information Summary | ||||
| Characteristic | Requirement | New Device | Predicate Device(s) | |
| Biocompatibility:Primary Skin Irritation | ISO 10993-1 | Meets requirements | Meets requirements | |
| Primary Skin Irritation | ISO 10993-10 | Pass | Pass | |
| Guinea Pig Maximization | ISO 10993-10 | Pass | Pass | |
| Dimensions | ASTM D3577 | Meets requirements | Meets requirements | |
| Physical Properties | ASTM D3577 | Meets requirements | Meets requirements | |
| Freedom from Holes | 21CFR 800.20 | Meets requirements | Meets requirements | |
| Powder Residual | & ASTM D3577ASTM D3577 | Meets requirements | Meets requirements | |
| Chemotherapy DrugPermeation | ASTM D6978 | Under the test conditionsprescribed by the test, theminimum normalizedbreakthrough detectiontimes for each of the 10chemotherapy drugs testedexceeded the maximumtesting time of 240 minutesexcept for Carmustine(BCNU) (3.3 mg/ml), whichshowed permeation time of0.20 minutes, and Thiotepa(10 mg/ml), which showedpermeation time of 82.2minutes. | Duraprene gloves clearedunder K013302 were testedwith 10 chemotherapy drugsin accordance with and metrequirements of ASTM F739standard. ASTM F739standard was superseded byASTM D6978-05. The testingmethod is the same. Thedifference is in that thethinnest area of the glove(palm or cuff) is tested andthe test results are reportedas minimum breakthroughtimes per ASTM D6978, asopposed to testing a randomspecimen and reporting theaverage breakthrough timesper ASTM F739. | |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCEAND/OR OF CLINICAL INFORMATION | ||||
| Clinical data is not required. | ||||
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA | ||||
| Non-clinical data demonstrates that Sterile Neoprene Powder-Free Surgical Gloves Tested for Use withChemotherapy Drugs meet the technological characteristics of ASTM D3577 standard, and are as safe, as |
Cardinal Health, Inc.
...'
Premarket Notification Submission -- Traditional 510(k)
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effective, and performed as well as the legally marketed devices identified in this summary.
Cardinal Health, Inc. Premarket Notification Submission – Traditional 510(k) 1
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three wing strokes, symbolizing strength and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Cardinal Health-Medical Products and Services C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, Illinois 60062
APR 2 7 2012
Re: K113707
Trade/Device Name: Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: April 16, 2012 Received: April 18, 2012
Dear Mr. Devine:
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. 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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Page 2 -- Mr. Devine
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Za
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510{k) Number (if known): K113705
Device Name:
Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating Tested for Use with Chemotherapy Drugs
These powder-free sterile light brown colored surgeon's gloves are a disposable Indications for Use: device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time inMinutes, 0.01 µg/cm²/minute | |
|---|---|---|
| 1. | Carmustine (BCNU) (3.3 mg/ml) | 0.20 |
| 2. | Cisplastin, (1.0 mg/ml) | >240 |
| 3. | Cyclophosphamide (20 mg/ml) | >240 |
| 4. | Doxorubicin HCl (2.0 mg/ml) | >240 |
| 5. | Etoposide (20 mg/ml) | >240 |
| 6. | Fluorouracil (50.0 mg/ml) | >240 |
| 7. | Methotrexate (25 mg/ml) | >240 |
| 8. | Paclitaxel (6.0 mg/ml) | >240 |
| 9. | Thiotepa (10.0 mg/ml) | 82.2 |
| 10. | Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that the following drug has extremely low permeation time of less than 30 minutes: Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 0.20 minute.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elisha P. Clavine Will
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: ビリタブのフ
Cardinal Health, Inc. Premarket Notification Submission - Traditional 510(k)
5
§ 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).