(177 days)
Not Found
No
The summary describes a surgical glove and its physical and chemical properties, with no mention of AI or ML technology.
No.
The device is a surgeon's glove designed for protection and not to treat or cure a disease or condition.
No
Explanation: The device is a surgeon's glove, intended to protect from contamination. It does not perform any diagnostic function.
No
The device is a physical glove made of synthetic rubber, not software. The summary describes physical characteristics, performance tests related to material properties, and intended use as a barrier device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect a surgical wound from contamination and to be worn by operating room personnel. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical properties and materials of a glove.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) to diagnose a condition, monitor a disease, or screen for a health issue.
- Performance Studies: The performance studies focus on physical characteristics, biocompatibility, and resistance to chemotherapy drugs. These are relevant to the glove's function as a protective barrier, not as a diagnostic tool.
- Key Metrics: The key metrics are related to the glove's physical and chemical properties, not diagnostic accuracy metrics like sensitivity or specificity.
An IVD is a medical device used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This glove does not perform any such tests.
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) | 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
Product codes
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 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.
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)
Biocompatibility:
- Primary Skin Irritation (ISO 10993-10): Non-Irritating, under the conditions of the study.
- Guinea Pig Maximization (ISO 10993-10): Non-sensitizing, under the conditions of the study.
Physical Characteristics:
- Dimensions (ASTM D3577): Meets requirements.
- Physical Properties (ASTM D3577): Meet requirements for synthetic surgical gloves.
- Freedom from Holes (21 CFR 800.20 & ASTM D3577): Tested in accordance with ASTM D 5151 and meets 21CFR 800.20 & ASTM D3577 requirements of AQL 1.5.
- Powder Residual (ASTM D3577 tested using ASTM standard D6124): Gloves meet powder level requirements for "Powder-Free" designation per ASTM D3577. Results generated values
§ 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/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
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 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
2
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 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
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.
3
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4
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, LLC
1500 Waukegan Road
Waukegan, IL 60085 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Megan Middaugh
1500 Waukegan Road
Waukegan, 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 Gloves
with 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 |
5
Image /page/5/Picture/0 description: The image shows the logo for Cardinal Health. 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.
Page 2 of_ 6
| Predicate Devices: | K113707 - Sterile Neoprene Powder-Free Surgical Gloves with
Nitrile 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 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. |
| 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: |
6
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.
7
| 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 coated | |
| with Nitrile | Synthetic Neoprene Polymer coated | |
| with Nitrile | ||
| Design | Hand Specific | |
| Independent Thumb | ||
| Beaded Cuff | ||
| Lubricated | Hand Specific | |
| Independent Thumb | ||
| Beaded Cuff | ||
| Lubricated | ||
| 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. | 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. | ||
| Indications for Use | 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. | 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 | ||
| Neoprene Surgical Glove with Nitrile | ||
| Coating | ||
| Not made with natural rubber latex | ||
| For Single Use Only | ||
| Tested for Use with Chemotherapy | ||
| Drugs | ||
| AQL 0.65 | Sterile | |
| Powder-free | ||
| Neoprene Surgical Glove with Nitrile | ||
| Coating | ||
| Not made with natural rubber latex | ||
| For Single Use Only | ||
| Tested for Use with Chemotherapy | ||
| Drugs | ||
| AQL 1.0 | ||
| 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- | ||
| 0:2010; 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 | ||
| Characteristic | Cardinal Health™ Sterile Neoprene | |
| Powder-free Surgical Gloves with | ||
| Nitrile Coating and Tested for Use with | ||
| Chemotherapy Drugs (Yellow) | ||
| (K153316) | Sterile Neoprene Powder-Free | |
| Surgical Glove w/Chemo Claim | ||
| (K113707) |
8
Table 3: Summary of Non-Clinical Tests
| 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 | Non-Irritating, under the conditions of the |
| study | ||
| Guinea Pig | ||
| Maximization | ISO 10993-10 | Non-sensitizing, under the conditions of the |
| study | ||
| Physical Characteristics: | ||
| Dimensions | ASTM D3577 | Meets requirements |
| Physical Properties | ASTM D3577 | Meet requirements for synthetic surgical |
| gloves | ||
| Freedom from Holes | 21 CFR 800.20 & | |
| ASTM D3577 | Tested in accordance with ASTM D 5151 | |
| and meets 21CFR 800.20 & ASTM | ||
| D3577 requirements of AQL 1.5 | ||
| Powder Residual | ASTM D3577 tested | |
| using ASTM | ||
| standard D6124 | Gloves meet powder level requirements for | |
| "Powder-Free" designation per ASTM | ||
| D3577. Results generated values |