(128 days)
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 m and the most go res world of Medical Gloves to Permeation by Chemotherapy Drugs.
The proposed device is a disposable device. It is not made with natural rubber latex. Instead, it is formulated from polyisoprene, which is a synthetic rubber latex. This Sterile Polyisoprene Powder-Free Surgical Glove is manufactured using exact same material used in the currently cleared device, Esteem SMT glove (K093300) that has been legally marketed by Cardinal Health. The glove is manufactured using molds that feature anti-slip finish, independent thumb, and tapered mechanically locking cuffs to help reduce cuff roll down. It is offered powder-free and sterile.
The provided document describes the safety and effectiveness summary for "Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy Drugs." This is for a medical device and not an AI or software device, therefore, the requested information elements related to AI/algorithm performance studies like sample size for test/training sets, data provenance, number/qualification of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable.
The acceptance criteria and the study proving the device meets these criteria are related to the physical, chemical, and biological properties of the surgical gloves.
1. A table of acceptance criteria and the reported device performance
| Characteristic | Acceptance Criteria (Standard/Test/FDA Guidance) | Reported Device Performance (New Device - K110272) |
|---|---|---|
| Biocompatibility: | ||
| Primary Skin Irritation | ISO 10993-10 | Gloves are non-irritating. (Pass) |
| Guinea Pig Maximization | ISO 10993-10 | Gloves do not display any potential for sensitization. (Pass) |
| Physical Characteristics: | ||
| Dimensions | ASTM D3577 | Meet requirements |
| 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 requirements. |
| Powder Residual | ASTM D3577 tested using ASTM D6124 | 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 | Under the test conditions prescribed by the test, the minimum normalized breakthrough detection times for each of the 25 chemotherapy drugs tested exceeded the maximum testing time of 240 minutes, except for Carmustine (BCNU) (3.3 mg/ml) and Thiotepa (10 mg/ml), which showed permeation time of less than 30 minutes (specifically, 0.37 min and 0.44 min respectively). This indicates the gloves are not protective against these two specific drugs for extended periods. |
| Chemotherapy Drug Permeation (Detailed values) | Minimum Breakthrough Detection Time (0.01 µg/cm²/min) > 240 minutes for acceptable protection (implied by the majority of test results). | Blenoxane (15 mg/ml): >240 min Busulfan (6 mg/ml): >240 min Carmustine (BCNU) (3.3 mg/ml): 0.37 min Cisplastin, (1.0 mg/ml): >240 min Cytarabine (100 mg/ml): >240 min Cyclophosphamide (20 mg/ml): >240 min Dacarbazine (10 mg/ml): >240 min Doxorubicin HCl (2.0 mg/ml): >240 min Ellence (25 mg/ml): >240 min Etoposide (Toposar) (20 mg/ml): >240 min Fludarabine (25 mg/ml): >240 min Fluorouracil (50 mg/ml): >240 min Idarubicin (1 mg/ml): >240 min Ifosfamide (50 mg/ml): >240 min Mechlorethamine HCl (1 mg/ml): >240 min Melphalan (5 mg/ml): >240 min Methotrexate (25 mg/ml): >240 min Mitoxantrone (2 mg/ml): >240 min Mitomycin C (0.5 mg/ml): >240 min Paclitaxel (Taxol) (6.0 mg/ml): >240 min Paraplatin (10 mg/ml): >240 min Rituximab (10 mg/ml): >240 min Thiotepa (10 mg/ml): 0.44 min Trisenox (0.1 mg/ml): >240 min Vincristine sulfate (1 mg/ml): >240 min |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for holes, or how many samples for biocompatibility). However, the tests were conducted according to recognized international and national standards (e.g., ISO 10993, ASTM D3577, ASTM D6978, 21 CFR 800.20), which typically specify appropriate sample sizes and methodologies.
The "data provenance" for this type of device (surgical gloves) would relate to the manufacturing and testing environment, not patient data. The tests are non-clinical, laboratory-based studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For surgical glove testing, "ground truth" is established by adherence to standardized test methods and criteria defined by organizations like ASTM and ISO, not by expert human consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical studies or for AI output evaluation. The tests performed for these gloves (e.g., physical properties, chemical permeation) are objective laboratory measurements, not requiring 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
Not applicable. This device is a physical medical glove, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical glove, not an AI or algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is established by objective laboratory measurements and adherence to predefined specifications and test standards. For example:
- Biocompatibility: Determined by standardized in-vivo (e.g., guinea pig maximization) and in-vitro tests following ISO 10993.
- Physical Properties: Measured against specifications in ASTM D3577.
- Freedom from Holes: Determined by testing according to ASTM D5151 and meeting AQL (Acceptable Quality Level) requirements specified in 21 CFR 800.20 & ASTM D3577.
- Powder Residual: Measured using ASTM D6124 to meet ASTM D3577 limits.
- Chemotherapy Drug Permeation: Measured as breakthrough time using ASTM D6978.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model 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 model.
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Image /page/0/Picture/0 description: The image shows the Cardinal Health logo. The logo consists of a stylized graphic above the company name. The graphic is made up of curved lines that resemble a bird in flight. The text "CardinalHealth" is written in a bold, sans-serif font.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
JUN - 8 2511
STERILE POLYISOPRENE 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 AffairsContact: | Tatyana Bogdan, RAC |
| Telephone: | 847-887-2325 |
| Fax: | 847-887-2717 |
| E-mail: | tatyana.bogdan-curvin@cardinalhealth.com |
| Summary Prepared: | May 13, 2011 |
| Trade Name: | Sterile Polyisoprene 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): | KGO |
| Legally marketeddevice(s) to whichequivalence is claimed: | 1. Esteem SMT Sterile Polyisoprene Powder-Free Surgical Gloves ( 510(k) K093300, product code KGO)2. Duraprene Sterile Neoprene Powder-Free Surgical Gloves (510(k) K013302, product code KGO) |
| Reason for 510(k)Submission: | Addition of new indications for use: Tested for Use with Chemotherapy Drugs |
| Device Description: | The proposed device is a disposable device. It is not made with natural rubberlatex. Instead, it is formulated from polyisoprene, which is a synthetic rubberlatex. This Sterile Polyisoprene Powder-Free Surgical Glove is manufacturedusing exact same material used in the currently cleared device, Esteem SMTglove (K093300) that has been legally marketed by Cardinal Health. The gloveis manufactured using molds that feature anti-slip finish, independent thumb,and tapered mechanically locking cuffs to help reduce cuff roll down. It isoffered powder-free and sterile. |
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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 m and the most go res world of Medical Gloves to Permeation by Chemotherapy Drugs:
| Chemotherapy Drug and Concentration | Min Breakthrough Detection Time, 0.01µg/cm²/minute | |
|---|---|---|
| 1. | Blenoxane (15 mg/ml) | >240 |
| 2. | Busulfan (6 mg/ml) | >240 |
| 3. | Carmustine (BCNU) (3.3 mg/ml) | 0.37 |
| 4. | Cisplastin, (1.0 mg/ml) | >240 |
| 5. | Cytarabine (100 mg/ml) | >240 |
| 6. | Cyclophosphamide (20 mg/ml) | >240 |
| 7. | Dacarbazine (10 mg/ml) | >240 |
| 8. | Doxorubicin HCl (2.0 mg/ml) | >240 |
| 9. | Ellence (25 mg/ml) | >240 |
| 10. | Etoposide (Toposar) (20 mg/ml) | >240 |
| 11. | Fludarabine (25 mg/ml) | >240 |
| 12. | Fluorouracil (50 mg/ml) | >240 |
| 13. | Idarubicin (1 mg/ml) | >240 |
| 14. | Ifosfamide (50 mg/ml) | >240 |
| 15. | Mechlorethamine HCl (1 mg/ml) | >240 |
| 16. | Melphalan (5 mg/ml) | >240 |
| 17. | Methotrexate (25 mg/ml) | >240 |
| 18. | Mitoxantrone (2 mg/ml) | >240 |
| 19. | Mitomycin C (0.5 mg/ml) | >240 |
| 20. | Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| 21. | Paraplatin (10 mg/ml) | >240 |
| 22. | Rituximab (10 mg/ml) | >240 |
| 23. | Thiotepa (10 mg/ml) | 0.44 |
| 24. | Trisenox (0.1 mg/ml) | >240 |
| 25. | 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 0.37 minute; Thiotepa (10 mg/ml) has a minimum breakthrough time of 0.44 minute.
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KIIO2112
| Summary of the technological characteristics of the device compared to the predicate device | ||||
|---|---|---|---|---|
| Characteristic | New Device(K110272) | PredicateSterile Polyisoprene PowderFree Surgical Glove(K093300) | PredicateSterile Neoprene Powder-Free Surgical Glove(K013302) | |
| MaterialComposition | Polyisoprene SyntheticRubber Latex | Polyisoprene SyntheticRubber Latex | Synthetic Neoprene Polymercoated with Nitrile | |
| Design | Single UseSterilePowder-freeHand SpecificIndependent ThumbBeaded CuffLubricated | Single UseSterilePowder-freeHand SpecificIndependent ThumbBeaded CuffLubricated | Single UseSterilePowder-freeHand SpecificIndependent ThumbBeaded CuffLubricated | |
| Intended Use | Powder-Free Surgeon'sGlove | Powder-Free Surgeon'sGlove | Powder-Free Surgeon'sGlove | |
| 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 D3577 requirements | AQL meets 21CFR 800.20 &ASTM D3577 requirements | AQL meets 21CFR 800.20 &ASTM D3577 requirements | |
| Powder Residual | Meets requirements of ≤2.0mg/glove for Powder-Freedesignation per ASTM D3577 | Meets requirements of ≤2.0mg/glove for Powder-Freedesignation per ASTM D3577 | Meets requirements of ≤2.0mg/glove for Powder-Freedesignation per ASTM D3577 | |
| PERFORMANCE DATA | ||||
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE* | ||||
| Performance Test Summary-New Device | ||||
| Characteristic | Standard/Test/FDA Guidance | 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 & ASTM D3577 | Tested in accordance with ASTM D5151 withacceptable results | ||
| Powder Residual | ASTM D3577 tested usingASTM standard D6124 | 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 drugstested exceeded the maximum testing time of | ||
| 240 minutes except for Carmustine (BCNU)(3.3 mg/ml) and Thiotepa (10 mg/ml), whichshowed permeation time of less than 30 minutes. | ||||
| Comparative Performance Information Summary | ||||
| Characteristic | Requirement | New Device | Predicate Device | |
| Biocompatibility: | 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& ASTM D3577 | Meets requirements | Meets requirements | |
| Powder Residual | ASTM D3577 | Meets requirements | Meets requirements | |
| Chemotherapy DrugPermeation | ASTM D6978 | Under the test conditionsprescribed by the test, theminimum normalizedbreakthrough detectiontimes for each of the 25chemotherapy drugs testedexceeded the maximumtesting time of 240 minutesexcept for Carmustine(BCNU) (3.3 mg/ml) andThiotepa (10 mg/ml), whichshowed permeation time ofless than 30 minutes. | 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. |
K110272 Traditional 510(k) Premarket Notification Submission – 510(k) Summary Cardinal Health, Inc.
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KHUJUL
and/or of clinical information
Clinical data is not required.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL AND CLINICAL DATA
Non-clinical data demonstrates that Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy Drugs 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.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Tatyana Bogdan Regulatory Affairs Manager Cardinal Health, Incorporated 1430 Waukegan Road McGaw Park, Illinois 60085
JUN - 8 2011
Re: K110272
Trade/Device Name: Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO, LZC Dated: May 12, 2011 Received: May 24, 2011
Dear Ms. 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.
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Page 2 - Ms. Bogdan
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/ucm115809.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.
Wh for
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
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Indications for Use
510(k) Number (if known): KLO27 L
Device Name:
Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy Drugs
Indications for Use: This powder-free surgeon's glove is a disposable device mate of synthetic Indications for Osc. This powder need bear.gooms gersonnel to protect a surgical wound from contamination.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM In addition, these gioves were tested for ass Min encation by Chemotherapy Drugs:
| Chemotherapy Drug andConcentration | Minimum Breakthrough Detection Timein Minutes, 0.01 μg/cm²/minute | |
|---|---|---|
| 1. | Blenoxane (15 mg/ml) | >240 |
| 2. | Busulfan (6 mg/ml) | >240 |
| 3. | Carmustine (BCNU) (3.3 mg/ml) | 0.37 |
| 4. | Cisplastin, (1.0 mg/ml) | >240 |
| 5. | Cytarabine (100 mg/ml) | >240 |
| 6. | Cyclophosphamide (20 mg/ml) | >240 |
| 7. | Dacarbazine (10 mg/ml) | >240 |
| 8. | Doxorubicin HCl (2.0 mg/ml) | >240 |
| 9. | Ellence (25 mg/ml) | >240 |
(Continued on next page)
X Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth F. Clavine-Williams
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K110272
Page / of 2
5
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| Continued from previous page) | ||
|---|---|---|
| Chemotherapy Drug andConcentration | Minimum Breakthrough Detection Timein Minutes, 0.01 µg/cm²/minute | |
| 10. | Etoposide (Toposar) (20 mg/ml) | >240 |
| 11. | Fludarabine (25 mg/ml) | >240 |
| 12. | Fluorouracil (50 mg/ml) | >240 |
| 13. | Idarubicin (1 mg/ml) | >240 |
| 14. | Ifosfamide (50 mg/ml) | >240 |
| 15. | Mechlorethamine HCl (1 mg/ml) | >240 |
| 16. | Melphalan (5 mg/ml) | >240 |
| 17. | Methotrexate (25 mg/ml) | >240 |
| 18. | Mitoxantrone (2 mg/ml) | >240 |
| 19. | Mitomycin C (0.5 mg/ml) | >240 |
| 20. | Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| 21. | Paraplatin (10 mg/ml) | >240 |
| 22. | Rituximab (10 mg/ml) | >240 |
| 23. | Thiotepa (10 mg/ml) | 0.44 |
| 24. | Trisenox (0.1 mg/ml) | >240 |
| 25. | 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 0.37 minute.
Thiotepa (10 mg/ml) has a minimum breakthrough time of 0.44 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)
Elizabeth F. Clausing-Williams
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices l
510(k) Number: K110272
Page 2 of 2
ర్
§ 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).