(177 days)
A powder-free sterile 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.
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 and is yellow in color.
The glove are manufactured using molds that feature anti-slip finish, independent thumb and mechanically locking cuffs to help prevent cuff roll down. They are offered powder-free and sterile. This glove is for single use only.
The provided document describes the acceptance criteria and the study for "Cardinal Health™ Sterile Neoprene Powder-free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)." This is a medical device, specifically a surgical glove, and the study focuses on its physical properties, biocompatibility, and resistance to chemotherapy drug permeation. There is no AI component mentioned in this documentation, therefore, several of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training) are not applicable.
Here's the breakdown of the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against various standards, primarily ASTM D3577 for surgical gloves and ASTM D6978 for chemotherapy drug permeation.
| Characteristic | Acceptance Criteria (Standard/Requirement) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Primary Skin Irritation | ISO 10993-10 Guidance | Non-Irritating, under the conditions of the study |
| Guinea Pig Maximization (Sensitization) | ISO 10993-10 Guidance | Non-sensitizing, under the conditions of the study |
| Physical Characteristics | ||
| Dimensions | ASTM D3577 requirements | Meets requirements |
| Physical Properties | ASTM D3577 requirements for synthetic surgical gloves | Meets requirements |
| Freedom from Holes | 21 CFR 800.20 & ASTM D3577 requirements of AQL 1.5; ASTM D 5151 test method | Tested in accordance with ASTM D 5151 and meets 21CFR 800.20 & ASTM D3577 requirements of AQL 1.5 |
| Powder Residual | ASTM D3577: ≤2.0 mg/glove for Powder-Free designation; ASTM D6124 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 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Minimum Breakthrough Detection Time 0.01 µg/cm²/minute | For 9 out of 11 chemotherapy drugs tested, the minimum normalized breakthrough detection times exceeded the maximum testing time of 240 minutes. Carmustine (BCNU) (3.3 mg/ml) showed a permeation time of 60.1 minutes, and Thiotepa (10 mg/ml) showed a permeation time of 110.5 minutes. (Specific values are listed in the Chemotherapy Drug Permeation Time table on page 3 and 6). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the various material tests. However, the tests are laboratory-based, adhering to international and ASTM standards. The provenance of the data is from Cardinal Health's testing, conducted for the purpose of FDA submission. The studies are by nature prospective, as they are performed on the device to prove its compliance with standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. These are physical and chemical performance tests, not clinical evaluations requiring human expert interpretation in the context of medical images or diagnoses. The "ground truth" for these tests is defined by the standards themselves (e.g., a specific breakthrough time, a dimensional tolerance, a AQL limit).
4. Adjudication Method for the Test Set
Not applicable. The tests involve objective measurements against predefined criteria/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 device is a surgical glove, not an AI-powered diagnostic tool. There are no human readers or AI involved in its performance evaluation as described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for performance assessment is based on established industry standards and regulatory requirements. For example:
- Physical properties (dimensions, tensile strength) are compared against ASTM D3577.
- Freedom from holes is assessed against 21 CFR 800.20 and ASTM D3577 AQL 1.5, using ASTM D5151.
- Powder residual is assessed against ASTM D3577 (< 2mg/glove), using ASTM D6124.
- Biocompatibility is assessed against ISO 10993-10 guidance (non-irritating, non-sensitizing).
- Chemotherapy drug permeation is assessed against ASTM D6978 (minimum breakthrough detection time).
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a physical device, not an AI algorithm.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 12, 2016
Cardinal Health 200, LLC. Ms. Megan Middaugh Manager, Regulatory Affairs 1500 Waukegan Road Waukegan, Illinois 60085
Re: K153316
Trade/Device Name: Cardinal Health™ Sterile Neoprene Powder-free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow) Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO, LZC Dated: April 15. 2016 Received: April 18, 2016
Dear Ms. Megan Middaugh:
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.
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
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, 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)
Device Name
Cardinal Health™ Sterile Neoprene Powder-free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)
Indications for Use (Describe)
A powder-free sterile 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 Time0.01 µg/cm²/minute | |
|---|---|---|
| 1. | Carmustine (BCNU) (3.3 mg/ml) | 60.1 |
| 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. | Mitomycin C (0.5 mg/ml) | >240 |
| 9. | Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| 10. | Thiotepa (10 mg/ml) | 110.5 |
| 11. | Vincristine Sulfate(1 mg/ml) | >240 |
CAUTION: Testing showed an average breakthrough time of 60.1 minutes with Carmustine
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/4/Picture/0 description: The image contains the logo for Cardinal Health. The logo consists of a stylized red bird-like design above the company name. The text "CardinalHealth" is written in a bold, sans-serif font, with the first letter of each word capitalized.
Cardinal Health 1500 Waukegan Road Waukegan, IL 60085 cardinalhealth.com
Page 1 of 6
510(k) SUMMARY
K153316
Cardinal Health™ Sterile Neoprene Powder-free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)
| Manufacturer: | Cardinal Health 200, LLC1500 Waukegan RoadWaukegan, IL 60085 |
|---|---|
| Regulatory Affairs Contact: | Megan Middaugh1500 Waukegan RoadWaukegan, IL 60085 |
| Telephone Number: | (847) 887-6812 |
| Fax Number: | (847) 887-2461 |
| Date Summary Prepared: | April 15, 2016 |
| Product Trade Name: | Cardinal Health™ Sterile Neoprene Powder-free Surgical Gloveswith Nitrile Coating and Tested for Use with Chemotherapy Drug(Yellow) |
| Common Name: | Surgeon's Gloves |
| Classification Name: | Surgeon's Gloves |
| Classification Panel: | General and Plastic Surgery |
| Regulation: | 21 CFR 878.4460 |
| Product Code: | KGO |
| Subsequent Product Code: | LZC |
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Page 2 of_ 6
| Predicate Devices: | K113707 - Sterile Neoprene Powder-Free Surgical Gloves withNitrile Coating Tested for Use with Chemotherapy Drugs |
|---|---|
| Reason for 510(k)Submission: | New device |
| Device Description: | The proposed device is a disposable device. It is not made withnatural rubber latex. Instead, the gloves are formulated usingneoprene synthetic polymer and are coated with nitrile coating andis yellow in color.The glove are manufactured using molds that feature anti-slipfinish, independent thumb and mechanically locking cuffs to helpprevent cuff roll down. They are offered powder-free and sterile.This glove is for single use only. |
| Intended Use: | A powder-free sterile surgeon's glove is a disposable devicemade of synthetic rubber intended to be worn by operating roompersonnel to protect a surgical wound from contamination.In addition, these gloves were tested for use with chemotherapydrugs in accordance with ASTM D6978 Standard Practice forAssessment of Medical Gloves to Permeation by ChemotherapyDrugs: |
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Table 1: Chemotherapy Drug Permeation Time
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time 0.01 µg/cm²/minute | |
|---|---|---|
| 1. | Carmustine (BCNU) (3.3 mg/ml) | 60.1 |
| 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. | Mitomycin C (0.5 mg/ml) | >240 |
| 9. | Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| 10. | Thiotepa (10 mg/ml) | 110.5 |
| 11. | Vincristine Sulfate (1 mg/ml) | >240 |
CAUTION: Testing showed an average breakthrough time of 60.1 minutes with Carmustine
Substantial Equivalence: The proposed device is substantially equivalent to the predicate device identified in this 510(k) summary. Substantial equivalence can be established in regard to intended use, physical properties and characteristics, design and product features. Both gloves are made of synthetic neoprene using similar manufacturing process.
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| Table 2: Summary of Technological Characteristics | ||
|---|---|---|
| Summary of the technological characteristics of the device compared to the predicate device | ||
|---|---|---|
| Characteristic | New Device | Predicate Device |
| Material Composition | Synthetic Neoprene Polymer coatedwith Nitrile | Synthetic Neoprene Polymer coatedwith Nitrile |
| Design | Hand SpecificIndependent ThumbBeaded CuffLubricated | Hand SpecificIndependent ThumbBeaded CuffLubricated |
| Intended Use | A powder-free sterile surgeon's glove isa disposable device made of syntheticrubber intended to be worn by operatingroom personnel to protect a surgicalwound from contamination. | These powder-free sterile light browncolored surgeon's gloves are adisposable device made of syntheticrubber intended to be worn byoperating room personnel to protect asurgical wound from contamination. |
| Indications for Use | In addition, these gloves were tested foruse with chemotherapy drugs inaccordance with ASTM D6978Standard Practice for Assessment ofMedical Gloves to Permeation byChemotherapy Drugs. | In addition, these gloves were testedfor use with chemotherapy drugs inaccordance with ASTM D6978Standard Practice for Assessment ofMedical Gloves to Permeation byChemotherapy Drugs. |
| Label Claims | SterilePowder-freeNeoprene Surgical Glove with NitrileCoatingNot made with natural rubber latexFor Single Use OnlyTested for Use with ChemotherapyDrugsAQL 0.65 | SterilePowder-freeNeoprene Surgical Glove with NitrileCoatingNot made with natural rubber latexFor Single Use OnlyTested for Use with ChemotherapyDrugsAQL 1.0 |
| Dimensions & PhysicalProperties | Meets ASTM D3577 | Meets ASTM D3577 |
| Freedom from Holes | Meets 21CFR 800.20 & ASTM D3577requirements of AQL 1.5 | Meets 21CFR 800.20 & ASTMD3577 requirements of AQL 1.5 |
| Powder Residual | Meets requirements of ≤2.0 mg/glovefor Powder-Free designation per ASTMD3577 | Meets requirements of ≤2.0 mg/glovefor Powder-Free designation perASTM D3577 |
| Biocompatibility(Irritation, ISO 10993-0:2010; Sensitization, ISO10993-10: 2010) | Non-Irritating, under the conditions ofthe studyNon-sensitizing, under the conditions ofthe study | Non-Irritating, under the conditionsof the studyNon-sensitizing, under the conditionsof the study |
| Characteristic | Cardinal Health™ Sterile NeoprenePowder-free Surgical Gloves withNitrile Coating and Tested for Use withChemotherapy Drugs (Yellow)(K153316) | Sterile Neoprene Powder-FreeSurgical Glove w/Chemo Claim(K113707) |
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Table 3: Summary of Non-Clinical Tests
| PERFORMANCE DATA | ||
|---|---|---|
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATIONOF SUBSTANTIAL EQUIVALENCE | ||
| Performance Test Summary-New Device | ||
| Characteristic | Standard/Test/FDAGuidance | Results Summary |
| Biocompatibility: | ||
| Primary SkinIrritation | ISO 10993-10 | Non-Irritating, under the conditions of thestudy |
| Guinea PigMaximization | ISO 10993-10 | Non-sensitizing, under the conditions of thestudy |
| Physical Characteristics: | ||
| Dimensions | ASTM D3577 | Meets requirements |
| Physical Properties | ASTM D3577 | Meet requirements for synthetic surgicalgloves |
| Freedom from Holes | 21 CFR 800.20 &ASTM D3577 | Tested in accordance with ASTM D 5151and meets 21CFR 800.20 & ASTMD3577 requirements of AQL 1.5 |
| Powder Residual | ASTM D3577 testedusing ASTMstandard D6124 | Gloves meet powder level requirements for"Powder-Free" designation per ASTMD3577. Results generated values < 2mg ofresidual powder per glove. |
| Chemotherapy DrugPermeation | ASTM D 6978 | Gloves were tested using ASTM D6978.Under the test conditions prescribed by thetest, the minimum normalized breakthroughdetection times for each of the chemotherapydrugs tested exceeded the maximum testingtime of 240 minutes except for Carmustine(BCNU) (3.3 mg/ml), which showedpermeation time of 60.1 minutes, andThiotepa (10 mg/ml), which showedpermeation time of 110.5 minutes |
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Table 4: Summary of Comparative Performance
| Comparative Performance Information Summary | |||
|---|---|---|---|
| Characteristic | Requirement | New Device | Predicate Device |
| Biocompatibility: | ISO 10993-1 | Meets requirements | Meets requirements |
| Primary Skin Irritation | ISO 10993-10 | Non-Irritating, under the conditions of the study | Non-Irritating, under the conditions of the study |
| Guinea Pig Maximization | ISO 10993-10 | Non-sensitizing, under the conditions of the study | Non-sensitizing, under the conditions of the study |
| Dimensions | ASTM D3577 | Meets requirements | Meets requirements |
| Physical Properties | ASTM D3577 | Meets requirements | Meets requirements |
| Freedom from Holes | 21CFR800.20, ASTM D3577 | Meets requirements | Meets requirements |
| Powder Residual | ASTM D3577 | Meets requirements | Meets requirements |
| Chemotherapy Drug Permeation | ASTM D6978 | Under the test conditions prescribed by the test, the minimum normalized breakthrough detection times for each of the 11 chemotherapy drugs tested exceeded the maximum testing time of 240 minutes except for Carmustine (BCNU) (3.3 mg/ml), which showed permeation time of 60.1 minutes, and Thiotepa (10 mg/ml), which showed permeation time of 110.5 minutes. | Under the test conditions prescribed by the test, the minimum normalized breakthrough detection times for each of the 10 chemotherapy drugs tested exceeded the maximum testing time of 240 minutes except for Carmustine (BCNU) (3.3 mg/ml), which showed permeation time of 0.20 minutes, and Thiotepa (10 mg/ml), which showed permeation time of 82.2 minutes. |
CAL TESTS CONDUCTED FOR SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
Clinical data is not required.
CONCLUSIONS DRAWN FROM NON-CLINICAL DATA
Non-clinical data demonstrates Cardinal Health™ Sterile Neoprene Powder-free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow) meet the technological characteristics of ASTM D3577 standard, and are as safe, as effective, and performed as well as the legally marketed devices identified in this summary.
§ 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).