(143 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:
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time,0.01 µg/cm²/minute | |
|---|---|---|
| 1. | Carmustine (BCNU) (3.3 mg/ml) | 17.9 |
| 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) | 40.3 |
| 10. | Vincristine Sulfate (1.0 mg/ml) | >240 |
WARNING: Do not use with Carmustine (BCNU) (3.3 mg/m1)
CAUTION: Testing showed an average breakthrough time of 40.3 minutes with Thiotepa (10 mg/ml).
The proposed device is a disposable device. It is not made with natural rubber latex. Instead, the gloves are formulated using polyisoprene and neoprene, which are synthetic rubber latex. The gloves 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.
Please find the requested information regarding the acceptance criteria and study details below.
1. Table of acceptance criteria and the reported device performance:
| Characteristic | Acceptance Criteria (Requirement) | Reported Device Performance (New Device) |
|---|---|---|
| Biocompatibility | ISO 10993-1 | Meets requirements |
| Primary Skin Irritation | ISO 10993-10 | Non-irritating, under the conditions of the study |
| Guinea Pig Maximization (Sensitization) | ISO 10993-10 | Non-sensitizing, under the conditions of the study |
| Dimensions | ASTM D3577 | Meets requirements |
| Physical Properties | ASTM D3577 | Meets requirements |
| Freedom from Holes | 21CFR800.20, ASTM D3577 | Meets requirements (AQL 1.5) |
| Chemotherapy Drug Permeation (ASTM D6978) | Varies by drug | - Carmustine (BCNU) (3.3 mg/ml): 17.9 minutes (WARNING: Do not use with this drug) - Cisplatin (1.0 mg/ml): >240 minutes - Cyclophosphamide (20 mg/ml): >240 minutes - Doxorubicin HCl (2.0 mg/ml): >240 minutes - Etoposide (Toposar) (20 mg/ml): >240 minutes - Fluorouracil (50 mg/ml): >240 minutes - Methotrexate (25 mg/ml): >240 minutes - Paclitaxel (Taxol) (6.0 mg/ml): >240 minutes - Thiotepa (10 mg/ml): 40.3 minutes (CAUTION: Testing showed an average breakthrough time of 40.3 minutes) - Vincristine Sulfate (1.0 mg/ml): >240 minutes |
| Powder Residual | ASTM D3577 (≤2.0 mg/glove) | Meets requirements (≤2.0 mg/glove for Powder-Free designation) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document does not explicitly state the sample size for each specific test (e.g., how many gloves were tested for permeation, how many samples for biocompatibility). However, it indicates compliance with standards like ASTM D3577 and ASTM D6978, which would inherently dictate minimum sample sizes for their respective tests.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The tests are reported as "conducted for determination of substantial equivalence."
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 surgical glove, and the "ground truth" for its performance is established through standardized laboratory tests (e.g., chemical permeation, physical properties) as per ASTM and ISO standards, not through expert consensus on interpretation of medical images or clinical outcomes.
4. Adjudication method for the test set:
- Not applicable. As noted above, performance is determined by objective laboratory measurements against established standards, not through adjudication of expert opinions.
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 a medical device (surgical glove), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (surgical glove), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the device's performance is based on objective measurements and results from standardized laboratory tests according to recognized industry standards (e.g., ASTM D6978 for chemotherapy drug permeation, ASTM D3577 for physical properties, ISO 10993 for biocompatibility).
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI model that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set is relevant for this device.
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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 15,2017
Cardinal Health, Inc. Tatyana Bogdan Director. Global Regulatory Affairs 1500 Waukegan Road Waukegan, Illinois 60085
Re: K170198
Trade/Device Name: Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White) Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO Dated: May 15, 2017 Received: May 16, 2017
Dear Tatyana Bogdan:
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.
Lori A. Wiggins -S6
Lori A. Wiggins, MPT, CLT Acting 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) K170198
Device Name
Cardinal Health™ Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White)
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 Time,0.01 µg/cm²/minute | |
|---|---|---|
| 1. | Carmustine (BCNU) (3.3 mg/ml) | 17.9 |
| 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) | 40.3 |
| 10. | Vincristine Sulfate (1.0 mg/ml) | >240 |
WARNING: Do not use with Carmustine (BCNU) (3.3 mg/m1)
CAUTION: Testing showed an average breakthrough time of 40.3 minutes with Thiotepa (10 mg/ml).
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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Image /page/3/Picture/0 description: The image contains the Cardinal Health logo. The logo consists of a stylized red bird-like symbol above the words "CardinalHealth" in a sans-serif font. The symbol is made up of several curved lines that resemble feathers or wings.
Cardinal Health 1500 Waukegan Road Waukegan, IL 60085 cardinalhealth.com
K170198 510(k) SUMMARY
Page 1 of 4
Cardinal Health™ Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White)
| Manufacturer: | Cardinal Health 200, LLC1500 Waukegan RoadWaukegan, IL 60085 |
|---|---|
| Regulatory Affairs Contact: | Tatyana Bogdan1500 Waukegan RoadWaukegan, IL 60085 |
| Telephone Number: | (847) 887-2325 |
| Fax Number: | (847) 887-2461 |
| Date Summary Prepared: | June 5, 2017 |
| Product Trade Name: | Cardinal Health™ Sterile Polyisoprene Blend Powder-FreeSurgical Gloves, Tested for Use with Chemotherapy Drugs(White) |
| 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 |
| Predicate Devices: | Cardinal Health™ Sterile Polyisoprene Powder-Free SurgicalGloves Tested for Use with Chemotherapy Drugs, previouslycleared under K110272 on June 08, 2011 |
| Reason for 510(k) |
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Image /page/4/Picture/0 description: The image contains the Cardinal Health logo. The logo consists of a stylized red bird-like design above the company name. The company name "CardinalHealth" is written in a bold, sans-serif font.
510(K) SUMMARY (CONT'D)
Cardinal Health 1500 Waukegan Road Waukegan, IL 60085 cardinalhealth.com
Page 2 of __ 4
| Device Description: | The proposed device is a disposable device. It is not made withnatural rubber latex. Instead, the gloves are formulated usingpolyisoprene and neoprene, which are synthetic rubber latex. |
|---|---|
| The gloves 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: |
Table 1: Chemotherapy Drug Permeation Time
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time0.01 µg/cm²/minute | |
|---|---|---|
| 1. | Carmustine (BCNU) (3.3 mg/ml) | 17.9 |
| 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) | 40.3 |
| 10. | Vincristine Sulfate (1.0 mg/ml) | >240 |
WARNING: Do not use with Carmustine (BCNU) (3.3 mg/ml)
CAUTION: Testing showed an average breakthrough time of 40.3 minutes with Thiotepa (10 mg/ml).
Substantial Equivalence:
Cardinal Health™ Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White), are substantially equivalent to Cardinal Health™ Sterile Polyisoprene Powder-Free Surgical Gloves in regard to intended use, sizes, physical characteristics, design, manufacturing process and product features.
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Image /page/5/Picture/0 description: The image contains the Cardinal Health logo. The logo consists of a stylized red graphic above the company name. The graphic is composed of several curved lines that resemble a bird in flight. The text "CardinalHealth" is written in a bold, sans-serif font.
Cardinal Health 1500 Waukegan Road Waukegan, IL 60085 cardinalhealth.com
Page 3 of __4
Table 2: Summary of Technological Characteristics
| Summary of the technological characteristics of the device compared to the predicate devices | ||
|---|---|---|
| Characteristic | New Device | Predicate Device |
| Material Composition | Cardinal Health™ Sterile Polyisoprene Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White) | Cardinal Health™ Sterile Polyisoprene Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (K110272) |
| Material Composition | Synthetic rubber blend of polyisoprene and neoprene | Synthetic Polyisoprene |
| Design | Hand SpecificIndependent ThumbBeaded CuffLubricated | Hand SpecificIndependent ThumbBeaded CuffLubricated |
| Intended Use /Indication for Use | 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. | 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. |
| Label Claims | SterilePowder-freeNot made with natural rubber latexSingle Use OnlyTested for Use with Chemotherapy DrugsAQL 0.65 (Freedom from Holes per ASTM D5151) | SterilePowder-freeNot made with natural rubber latexSingle Use OnlyTested for Use with Chemotherapy DrugsAQL 0.65 (Freedom from Holes per ASTM D5151) |
| Dimensions &Physical Properties | Meets ASTM D3577 | Meets ASTM D3577 |
| Freedom from Holes | Meets 21CFR 800.20 & ASTM D3577requirements of AQL 1.5 | Meets 21CFR 800.20 & ASTM D3577requirements of AQL 1.5 |
| Powder Residual | Meets requirements of ≤2.0 mg/glove forPowder-Free designation per ASTM D3577 | Meets requirements of ≤2.0 mg/glove forPowder-Free designation per ASTM D3577 |
| Biocompatibility(Irritation, ISO10993-10:2010;Sensitization, ISO10993-10: 2010) | Non-Irritating, under the conditions of the studyNon-sensitizing, under the conditions of the study | Non-Irritating, under the conditions of the studyNon-sensitizing, under the conditions of the study |
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Image /page/6/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a stylized red bird-like design above the company name. The name "CardinalHealth" is written in a bold, sans-serif font, with "Cardinal" and "Health" connected as one word.
Cardinal Health 1500 Waukegan Road Waukegan, IL 60085 cardinalhealth.com
Page 4 of 4
Table 3: Summary of Comparative Performance
| Comparative Performance Information Summary | |||
|---|---|---|---|
| Characteristic | Requirement | New DeviceCardinal Health™ SterilePolyisoprene Blend Powder-FreeSurgical Gloves, tested for Usewith Chemotherapy Drugs (White) | Predicate DeviceCardinal Health™ SterilePolyisoprene Powder-FreeSurgical Gloves, Tested for Usewith Chemotherapy Drugs(K110272) |
| Biocompatibility: | ISO 10993-1 | Meets requirements | Meets requirements |
| Primary SkinIrritation | ISO 10993-10 | Non-irritating, under theconditions of the study | Non-irritating, under theconditions of the study |
| Guinea PigMaximization | ISO 10993-10 | Non-sensitizing, under theconditions of the study | Non-sensitizing, under theconditions 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 |
| Chemotherapy DrugPermeation | ASTM D6978 | Gloves were tested using ASTMD6978. Under the test conditionsprescribed by the test, theminimum normalizedbreakthrough detection times foreach of the chemotherapydrugs tested exceeded themaximum testing time of 240minutes except for Carmustine(BCNU) (3.3 mg/ml), whichshowed permeation time of 17.9minutes, and Thiotepa (10 mg/ml),which showed permeation time of40.3 minutes. | Gloves were tested using ASTMD6978. |
| Powder Residual | ASTM D3577 | Meets requirements | Meets requirements |
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF 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 Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White), meet the technological characteristics of ASTM D3577 standard, and are as safe, as effective, and performs as well as the legally marketed device 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).