(133 days)
Not Found
No
The device is a surgical glove and the summary does not mention any AI or ML capabilities. The performance studies focus on physical properties and chemotherapy drug permeation, not algorithmic performance.
No
The device is a surgical glove intended to protect personnel and prevent contamination, not to treat a medical condition or ailment.
No
The device description and intended use clearly state that these gloves are for protection against contamination and for use with chemotherapy drugs, not for diagnosing any condition.
No
The device is a physical surgical glove made of synthetic latex rubber, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device's Intended Use: The intended use of these gloves is to be worn by operating room personnel to protect a surgical wound from contamination and for use with chemotherapy drugs. This is a barrier function and protection for the user and the patient's wound, not for examining specimens from the body to provide diagnostic information.
- Device Description: The description confirms it's a disposable glove for wearing on hands.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, diagnostic testing, or providing information about a patient's health status based on in vitro examination.
Therefore, based on the provided information, this device clearly falls outside the definition and purpose of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination, and are tested for use with chemotherapy drugs.
Product codes (comma separated list FDA assigned to the subject device)
KGO, LZC
Device Description
The Derma Prene® Isotouch® Green Sterile Powder-Free Polyisoprene Surgical Gloves, Tested for Use with Chemotherapy Drugs, is a disposable device made of synthetic latex rubber that is intended to be worn by operating room personnel to protect a surgical wound from contamination, and is tested for use with chemotherapy drugs. A coating of Aliphatic Polyester Polyurethane is applied to the inner surface of the glove to make donning easy.
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)
Chemotherapy Drug Permeation (average breakthrough detection time in minutes) (ASTM D6978-05) was tested and results for various chemotherapy drugs are provided, with Carmustine and ThioTEPA showing a 15.5 minute permeation time and others showing >240 minutes. The device meets ASTM D3577-09e1 for Dimensions, Physical Properties, and Freedom from Holes; ASTM D 5151-06 for Freedom from Holes; ASTM D 6124-06 for Powder-Free (≤ 2 mg per glove); ASTM D3577-09e1 and ASTM D 5712 for Protein Content (Maximum 50 µg/dm²). Biocompatibility studies for Dermal Sensitization and Primary Skin Irritation Study passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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).
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Image /page/0/Picture/1 description: The image shows the word "Ansell" in a bold, sans-serif font. The word is underlined with a thick, slightly curved line. The text and the line are both black, contrasting with the white background.
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1635 Industrial Road Dothan, AL 36303 Tel: (334) 615-2563 Fax: (334) 615-2574
510(k) SUMMARY
1.0 Submitter: Ansell Healthcare Products LLC 1635 Industrial Road Dothan, AL 36303
2.0 Date of Preparation: July 21, 2011
3.0 Contact Information: Cynthia A. Ingram, Regulatory Affairs Manager, Americas Fax: 334-615-2573 Telephone: 334-615-2563
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4.0 Name of Device: Trade Name: Derma Prene® Isotouch® Green Sterile Powder-Free Polyisoprene Surgical Gloves, Tested for Use with Chemotherapy Drugs
Common Name: Surgeon's Gloves Classification Name: Surgeon's Gloves -
Legally Marketed Device to Which Equivalence is being Claimed: રું. વ
Device Name: Cardinal Health Duraprene SMT Powder-Free Synthetic Neoprene Surgical Gloves Tested for Use with Chemotherapy Drugs
510(k) Number: K013302
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6.0 Identification of the Device:
Derma Prene® Isotouch® Green Sterile Powder-Free Polyisoprene Surgical Gloves, Tested for Use with Chemotherapy Drugs -
7.0 Description of the Device:
The Derma Prene® Isotouch® Green Sterile Powder-Free Polyisoprene Surgical Gloves, Tested for Use with Chemotherapy Drugs, is a disposable device made of synthetic latex rubber that is intended to be worn by operating room personnel to protect a surgical wound from contamination, and is tested for use with chemotherapy drugs. A coating of Aliphatic Polyester Polyurethane is applied to the inner surface of the glove to make donning easy.
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8.0 Intended Use of the Device:
These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination, and are tested for use with chemotherapy drugs.
Chemotherapy Drug Permeation (average breakthrough detection time in minutes) (ASTM D6978-05)
| *Carmustine | 15.5 |
|---|---|
| Cyclophosphamide | >240 |
| Doxorubicin Hydrochloride | >240 |
| Etoposide (Toposar) | >240 |
| 5-Fluorouracil | >240 |
| Paclitaxel (Toxol) | >240 |
| *ThioTEPA | 15.5 |
| Methotrexate | >240 |
| Vincristine Sulfate | >240 |
Please note that Carmustine and ThioTEPA have an extremely low permeation time of 15.5 minutes.
ਰੇ.0 Summary of Technological Characteristics of the Device:
Derma Prene® Isotouch® Green Sterile Powder-Free Polyisoprene Surgical Gloves, Tested for Use with Chemotherapy Drugs have the following technological characteristics compared to ASTM or equivalent standards:
| Characteristics | Standard | Device Performance |
|---|---|---|
| Dimensions | ASTM D3577-09e1 | Meets |
| Physical Properties | ASTM D3577-09e1 | Meets |
| Freedom from Holes | ASTM D3577-09e1 | Meets |
| ASTM D 5151-06 | ||
| Powder-Free | ASTM D 6124-06 | ≤ 2 mg per glove |
| Protein Content | ASTM D3577-09e1 | Maximum 50 µg/dm² |
| ASTM D 5712 | ||
| Biocompatibility | Dermal Sensitization | Passes |
| Primary Skin Irritation Study | Passes |
2
Substantial Equivalence Based on Assessment of Non-Clinical Performance Data: 10.0
Comparison to Predicate – The subject device (Derma Prené® Isotouch® Green Sterile Powder-Free Polyisoprene Surgical Gloves, Tested for Use with Chemotherapy Drugs) compares favorably to the predicate device (Cardinal Health Duraprene SMT Powder-Free Synthetic Neoprene Surgical Gloves Tested for Use with Chemotherapy Drugs) as indicated in the tabulated summary below.
| Substantial Equivalence Comparison Table | |||
|---|---|---|---|
| Subject Device | Predicate Device | Substantial | |
| Equivalence (SE)? | |||
| Derma Prene® Isotouch® Green | |||
| Sterile Powder-Free | |||
| Polyisoprene Surgical Gloves, | |||
| Tested for Use with | |||
| Chemotherapy Drugs | Cardinal Health Duraprene SMT | ||
| Gloves, Tested for Use with | |||
| Chemotherapy Drugs | |||
| (Allegiance Healthcare | |||
| Corporation K013302) | |||
| Indications for | |||
| Use | These gloves are intended to be | ||
| worn by operating room | |||
| personnel to protect a surgical | |||
| wound from contamination, and | |||
| are tested for use with | |||
| chemotherapy drugs. | These gloves are intended for | ||
| use in environments within | |||
| hospitals and other healthcare | |||
| facilities. The gloves are | |||
| appropriate for use during | |||
| invasive as well as non-invasive | |||
| medical procedures requiring | |||
| sterility. They are intended to | |||
| be worn by operating room | |||
| personnel to protect a surgical | |||
| wound form contamination. | Yes, Substantially | ||
| Equivalent | |||
| Chemotherapy | |||
| Permeation | |||
| Standard | Meets ASTM D6978-05 | Meets ASTM F739-91 | Yes, Substantially |
| Equivalent | |||
| Design | |||
| Specifications | Meets ASTM D3577-09e1 | Meets ASTM D3577 and | |
| EN 455-2 | Yes, Substantially | ||
| Equivalent | |||
| Performance | Meets ASTM D3577-09e1 | Meets ASTM D3577 and | |
| EN 455-2 | Yes, Substantially | ||
| Equivalent | |||
| Materials | Flexible Synthetic Rubber - | ||
| Synthetic Polyisoprene Rubber | |||
| and Aliphatic Polyester | |||
| Polyurethane inner coating to | |||
| aid donning | Flexible Synthetic Rubber - | ||
| Neoprene and Nitrile for easy | |||
| donning | Yes, Substantially | ||
| Equivalent | |||
| Biocompatibility | Passes | Passes | Yes, Substantially |
| Equivalent | |||
| Sterility | Sterile | Sterile | Identical |
| Color | Synthetic Glove with embedded | ||
| Colorant -Green | Synthetic Glove with embedded | ||
| Colorant -Flesh | Yes, Substantially | ||
| Equivalent | |||
| Powder-Free | Meets Applicable Definition for | ||
| Powder Free: 240 | |||
| Doxorubicin Hydrochloride | >240 | ||
| Etoposide (Toposar) | >240 | ||
| 5-Fluorouracil | >240 | ||
| Paclitaxel (Taxol) | >240 | ||
| *ThioTEPA | 15.5 | ||
| Methotrexate | >240 | ||
| Vincristine Sulfate | >240 |
Please note that Carmustine and ThioTEPA have an extremely low permeation time of 15.5 minutes.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE FF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Elishath F. Clavie-Wells
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _K !!!! 3 9