(143 days)
Not Found
No
The 510(k) summary describes a physical medical device (surgical gloves) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The testing described relates to material properties and chemical resistance.
No
The device is a surgeon's glove intended to protect a surgical wound from contamination and for protection against chemotherapy drugs, not to provide therapy.
No
The text describes a surgeon's glove, which is a protective barrier, not a device used to identify or determine a disease or condition. Its purpose is to protect against contamination and chemotherapy drugs, not to diagnose.
No
The device described is a physical medical device (surgical gloves) and does not involve any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is to be worn by operating room personnel to protect a surgical wound from contamination. This is a barrier function for infection control.
- Chemotherapy Drug Testing: While the gloves are tested for use with chemotherapy drugs, this testing is related to the glove's barrier properties against these substances, not for diagnosing a condition or providing information about a patient's health.
- Device Description: The description focuses on the physical properties and materials of the glove.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
IVD devices are specifically designed to perform tests on biological samples (like blood, urine, tissue) to provide diagnostic information. This glove does not perform such a function.
N/A
Intended Use / Indications 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:
| 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).
Product codes (comma separated list FDA assigned to the subject device)
KGO, LZC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Minimum Breakthrough Detection Time (0.01 µg/cm²/minute) for various chemotherapy drugs.
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).
AQL 0.65 (Freedom from Holes per ASTM D5151)
Meets 21CFR 800.20 & ASTM D3577 requirements of AQL 1.5 for Freedom from Holes.
Meets requirements of ≤2.0 mg/glove for Powder-Free designation per ASTM D3577.
Biocompatibility: Non-Irritating, Non-sensitizing under the conditions of the study.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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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3
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, LLC
1500 Waukegan Road
Waukegan, IL 60085 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Tatyana Bogdan
1500 Waukegan Road
Waukegan, 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-Free
Surgical 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 Surgical
Gloves Tested for Use with Chemotherapy Drugs, previously
cleared under K110272 on June 08, 2011 |
| Reason for 510(k) | |
4
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 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. |
| Intended 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: |
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) | 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 Specific | |
| Independent Thumb | ||
| Beaded Cuff | ||
| Lubricated | Hand Specific | |
| Independent Thumb | ||
| Beaded Cuff | ||
| Lubricated | ||
| 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 | Sterile | |
| Powder-free | ||
| Not made with natural rubber latex | ||
| Single Use Only | ||
| Tested for Use with Chemotherapy Drugs | ||
| AQL 0.65 (Freedom from Holes per ASTM D5151) | Sterile | |
| Powder-free | ||
| Not made with natural rubber latex | ||
| Single Use Only | ||
| Tested for Use with Chemotherapy Drugs | ||
| AQL 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 D3577 | |
| requirements of AQL 1.5 | Meets 21CFR 800.20 & ASTM D3577 | |
| requirements of AQL 1.5 | ||
| Powder Residual | Meets requirements of ≤2.0 mg/glove for | |
| Powder-Free designation per ASTM D3577 | Meets requirements of ≤2.0 mg/glove for | |
| Powder-Free designation per ASTM D3577 | ||
| Biocompatibility | ||
| (Irritation, ISO | ||
| 10993-10:2010; | ||
| Sensitization, ISO | ||
| 10993-10: 2010) | Non-Irritating, under the conditions of the study | |
| Non-sensitizing, under the conditions of the study | Non-Irritating, under the conditions of the study | |
| Non-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 Device | |
| Cardinal Health™ Sterile | |||
| Polyisoprene Blend Powder-Free | |||
| Surgical Gloves, tested for Use | |||
| with Chemotherapy Drugs (White) | Predicate Device | ||
| Cardinal Health™ Sterile | |||
| Polyisoprene Powder-Free | |||
| Surgical Gloves, Tested for Use | |||
| with Chemotherapy Drugs | |||
| (K110272) | |||
| 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 | |
| Chemotherapy Drug | |||
| Permeation | ASTM D6978 | Gloves were tested using ASTM | |
| D6978. Under the test conditions | |||
| prescribed by the test, the | |||
| minimum normalized | |||
| breakthrough detection times for | |||
| each of the chemotherapy | |||
| drugs tested exceeded the | |||
| maximum testing time of 240 | |||
| minutes except for Carmustine | |||
| (BCNU) (3.3 mg/ml), which | |||
| showed permeation time of 17.9 | |||
| minutes, and Thiotepa (10 mg/ml), | |||
| which showed permeation time of | |||
| 40.3 minutes. | Gloves were tested using ASTM | ||
| D6978. | |||
| 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.