(133 days)
No
The 510(k) summary describes a surgical glove and its physical and chemical properties. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No
The device is a surgeon's glove, intended to protect from contamination, not to treat or cure a disease or condition.
No
Explanation: The device described is a surgeon's glove, intended to protect a surgical wound from contamination and for use with chemotherapy drugs. It is a protective barrier, not a device used to diagnose a medical condition.
No
The device described is a physical medical device (surgical gloves) and the summary focuses on material properties, physical characteristics, and chemotherapy drug permeation, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: An In Vitro Diagnostic device is a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Intended Use of the Device: The intended use of these gloves is clearly stated as being worn by operating room personnel to protect a surgical wound from contamination and for protection against chemotherapy drugs. This is a protective barrier function, not a diagnostic function.
- Device Description: The device description focuses on the material, manufacturing process, and physical features of the gloves. There is no mention of any components or functions related to analyzing biological samples.
- Performance Studies: The performance studies described are related to the physical properties, biocompatibility, and barrier function against chemotherapy drugs. There are no studies related to diagnostic accuracy or the analysis of biological samples.
The fact that the gloves were tested for permeation by chemotherapy drugs is a safety and performance characteristic, not a diagnostic one. It indicates the level of protection the gloves provide against these substances, which is relevant to their use as a protective barrier in a clinical setting.
N/A
Intended Use / Indications for 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 D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Product codes
79KGO
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. The gloves are manufactured using exact same material used in the currently cleared device, Duraprene SMT gloves, that have been legally marketed by Cardinal Health under K102500. The gloves are manufactured using molds that feature anti-slip finish, independent thumb, and tapered mechanically locking cuffs to help reduce cuff roll down. They are light brown in color and are offered powder-free and sterile.
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: Tested according to ISO 10993-10. Results: Gloves are non-irritating.
- Guinea Pig Maximization: Tested according to ISO 10993-10. Results: Gloves do not display any potential for sensitization.
Physical Characteristics:
- Dimensions: Tested according to ASTM D3577. Results: Meet requirements.
- Physical Properties: Tested according to ASTM D3577. Results: Meet requirements for rubber surgical gloves.
- Freedom from Holes: Tested according to 21 CFR 800.20 & ASTM D3577. Results: Tested in accordance with ASTM D5151 with acceptable results.
- Powder Residual: Tested according to ASTM D3577 using ASTM D6124 standard test method. Results: 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
. רכת (KI3707)
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APR 2 7 2012
Image /page/0/Picture/3 description: The image shows the logo for Cardinal Health. The logo consists of a stylized bird-like graphic above the company name. The company name, "CardinalHealth", is written in a bold, sans-serif font, with the first letter of each word capitalized.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES
(A summary of safety and effectiveness information in accordance with the requirements of 21 CFR
807.92)
| Applicant: | Cardinal Health
1430 Waukegan Road
McGaw Park, IL 60085 |
|-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration Number: | 1423537 |
| Regulatory Affairs | |
| Contact: | Tatyana Bogdan, RAC |
| Telephone: | 847-887-2325 |
| Fax: | 847-887-2717 |
| E-mail: | tatyana.bogdan-curvin@cardinalhealth.com |
| Summary Prepared: | November 13, 2011 |
| Trade Name: | Sterile Neoprene Powder-Free Surgical Gloves Tested for Use with
Chemotherapy 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): | 79KGO |
| Legally marketed
device(s) to which
equivalence is claimed: | 1. Duraprene SMT Sterile Polyisoprene Powder-Free Surgical Gloves,
510(k) K102500, (product code 79KGO).
2. Duraprene Sterile Neoprene Powder-Free Surgical Gloves, 510(k)
K013302, (product code 79KGO) |
| 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 rubber
latex. Instead, the gloves are formulated using neoprene synthetic polymer and
are coated with nitrile coating. The gloves are manufactured using exact same
material used in the currently cleared device, Duraprene SMT gloves, that have |
Cardinal Health, Inc.
Premarket Notification Submission -- Traditional 510(k).
б
1
been legally marketed by Cardinal Health under K102500. The gloves are manufactured using molds that feature anti-slip finish, independent thumb, and tapered mechanically locking cuffs to help reduce cuff roll down. They are light brown in color and are offered powder-free and sterile.
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 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) | 0.20 |
| 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) | 82.2 |
| 10. | 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 0.20 minute.
Summary of the technological characteristics of the device compared to the predicate device:
| Characteristic | Subject Device
Sterile Neoprene Powder-
Free Surgical Glove
w/Chemo Claim | Predicate
Sterile Neoprene Powder-
Free Surgical Glove
(K102500) | Predicate
Sterile Neoprene Powder-
Free Surgical Glove
(K013302) |
|-------------------------|------------------------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Design | Single Use | Single Use | Single Use |
| | Sterile | Sterile | Sterile |
| | Powder-free | Powder-free | Powder-free |
| | Hand Specific | Hand Specific | Hand Specific |
| | Independent Thumb | Independent Thumb | Independent Thumb |
| | Beaded Cuff | Beaded Cuff | Beaded Cuff |
| | Lubricated | Lubricated | Lubricated |
| Material
Composition | Synthetic Neoprene
Polymer coated with
Nitrile | Synthetic Neoprene
Polymer coated with
Nitrile | Synthetic Neoprene
Polymer coated with
Nitrile |
| Intended Use | Powder-Free Surgeon's
Glove | Powder-Free Surgeon's
Glove | Powder-Free Surgeon's
Glove |
Cardinal Health, Inc. Premarket Notification Submission - Traditional 510(k)
7
2
| Indications for Use | | Tested for Use with
Chemotherapy Drugs | Not Tested | Tested for Use with
Chemotherapy Drugs |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimensions &
Physical Properties | | Meets ASTM D3577 | Meets ASTM D3577 | Meets ASTM D3577 |
| Freedom from
Holes | | 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
240 |
| 3. | Cyclophosphamide (20 mg/ml) | >240 |
| 4. | Doxorubicin HCl (2.0 mg/ml) | >240 |
| 5. | Etoposide (20 mg/ml) | >240 |
| 6. | Fluorouracil (50.0 mg/ml) | >240 |
| 7. | Methotrexate (25 mg/ml) | >240 |
| 8. | Paclitaxel (6.0 mg/ml) | >240 |
| 9. | Thiotepa (10.0 mg/ml) | 82.2 |
| 10. | Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that the following drug has extremely low permeation time of less than 30 minutes: Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 0.20 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)
Elisha P. Clavine Will
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: ビリタブのフ
Cardinal Health, Inc. Premarket Notification Submission - Traditional 510(k)
5