(48 days)
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Not Found
No
The 510(k) summary describes a medical glove and its performance against established standards. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No
Explanation: This device is a medical glove intended to prevent contamination, not to treat, mitigate, or cure a disease or condition. Its function is protective, not therapeutic.
No
The device is described as a medical glove intended to prevent contamination, not to diagnose medical conditions or diseases.
No
The device description clearly identifies it as a physical medical glove, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the glove is for preventing contamination between healthcare personnel and patients/their environment. This is a barrier function, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description focuses on the physical properties and standards met by the glove, consistent with a medical device used for protection.
- Performance Studies: The performance studies described are related to the physical integrity, biocompatibility, and barrier properties of the glove (e.g., freedom from holes, chemotherapy drug permeation). These are not studies related to analyzing biological samples for diagnostic purposes.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not perform such a function.
N/A
Intended Use / Indications for Use
Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use) are non-sterile disposable devices to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment and for use in handling chemotherapy drugs.
This is a medical glove to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment, and tested for use with chemotherapy drugs.
Chemotherapy Drug Permeation (average breakthrough detection time in minutes) (ASTM D6978-05)
| *Carmustine | 45.27 |
| Cyclophosphamide | >240 |
| Doxorubicin Hydrochloride | >240 |
| Etoposide (Toposar) | >240 |
| 5-Fluorouracil | >240 |
| Paclitaxel (Toxol) | >240 |
| Thio-Tepa | 93.50 |
| Vincristine Sulfate | >240 |
| Methotrexate | >240 |
*Caution: Testing showed an average breakthrough time of 45 minutes with Carmustine.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use) meet all of the requirements of ASTM D 6319-00a(2005).
Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use) meet all of the current specifications of ASTM D6319-00a(2005), Standard Specification for Nitrile Examination Gloves for Medical Application.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hands
Indicated Patient Age Range
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Intended User / Care Setting
health care and similar personnel
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device met the following standards:
- ASTM D 6319-00a(2005) for Dimensions, Physical Properties, and Freedom from Holes.
- ASTM D 5151-06 for Holes.
- ASTM D 6124-06 for Powder-Free (≤2 mg per glove).
- ISO Skin Irritation Study (Passes).
- ISO Maximization Sensitization Study - Extract (Passes).
- Cytotoxicity Study Using the End-Point Titration Method (Non-toxic at 24 hours for dilutions 1:2 through 1:32).
- ASTM D 6978-05 for Chemotherapy Drug Permeation with specific average breakthrough times for various drugs, including:
- Carmustine: 45.27 minutes
- Cyclophosphamide: >240 minutes
- Doxorubicin Hydrochloride: >240 minutes
- Etoposide (Toposar): >240 minutes
- 5-Fluorouracil: >240 minutes
- Paclitaxel (Toxol): >240 minutes
- Thio-Tepa: 93.50 minutes
- Vincristine Sulfate: >240 minutes
- Methotrexate: >240 minutes
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
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 Contact Information:
Cynthia A. Ingram, Regulatory Affairs Manager, Americas Telephone: (334) 615-2563 Fax: (334) 615-2568
SEP 2 1 2009
3.0 Name of Device:
Trade Name: Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use)
Patient Examination Gloves Common Name:
Classification Name: Glove, Patient Examination, Nitrile
- 4.0 Identification of the Device:
Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use) meet all of the requirements of ASTM D 6319-00a(2005).
5.0 Description of the Device:
Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use) meet all of the current specifications of ASTM D6319-00a(2005), Standard Specification for Nitrile Examination Gloves for Medical Application.
6.0 Intended Use of the Device:
Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use) are non-sterile disposable devices to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment and for use in handling chemotherapy drugs.
7.0 Summary of Technological Characteristics of the Device:
Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use) are summarized with the following technological characteristics compared to ASTM or equivalent standards.
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| Characteristics | Standard | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-00a(2005) | Meets |
| Physical Properties | ASTM D 6319-00a(2005) | Meets |
| Freedom from | ||
| Holes | ASTM D 6319-00a(2005) | Meets |
| Holes | ASTM D 5151-06 | Meets |
| Powder-Free | ASTM D 6124-06 | ≤2 mg per glove |
| Biocompatibility | ISO Skin Irritation Study | Passes |
| ISO Maximization | ||
| Sensitization Study - Extract | ||
| Cytotoxicity Study Using the | ||
| End-Point Titration Method | Passes | |
| Non-toxic at 24 hours for | ||
| dilutions 1:2 through 1:32 | ||
| Chemotherapy | ||
| Drug | ||
| Permeation Test | ASTM D 6978-05 | Chemotherapy Drug Permeation |
| (average breakthrough time in | ||
| minutes) | ||
| Carmustine 45.27 | ||
| Cyclophosphamide >240 | ||
| Doxorubicin Hydrochloride >240 | ||
| Etoposide (Toposar) >240 | ||
| 5-Fluorouracil >240 | ||
| Paclitaxel (Toxol) >240 | ||
| Thio-Tepa 93.50 | ||
| Vincristine Sulfate >240 | ||
| Methotrexate >240 |
8.0 Substantial Equivalence Based on Assessment of Non-Clinical Performance Data:
The performance test data of the non-clinical tests are the same as mentioned immediately above.
9.0 Substantial Equivalence Based on Assessment of Clinical Performance Data:
Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process.
10.0 Conclusion:
It is concluded that Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use) are as safe, as effective, and perform as well as the glove performance standards referenced in Section 7 above and therefore meet:
ASTM listed standards, FDA hole requirements, and labeling claims for the product.
This device is substantially equivalent to currently marketed devices.
This summary will include any other information reasonably deemed necessary by the FDA.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ansell Healthcare Products LLC C/O Mr. Casey Conry Responsible Third Party Official Underwriters Laboratories. Incorporated 1285 Walt Whitman Road Melville, New York 11747
Re: K092327
Trade/Device Name: Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves, Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250
Regulation Name: Patient Examination Glove
Regulatory Class: I . Product Code: LZA, LZC Dated: September 4, 2009
Received: September 8, 2009
Dear Mr. Conry:
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.
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.
3
Page 2- Mr. Conry
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/Reporta Problem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Anthony D. Archer
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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3.0 Indications for Use Statement:
INDICATIONS FOR USE
510(K) Number (if known): K092327
Device Name:
Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves, Tested for Use with Chemotherapy Drugs
Indications For Use:
This is a medical glove to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment, and tested for use with chemotherapy drugs.
Chemotherapy Drug Permeation (average breakthrough detection time in minutes) (ASTM D6978-05)
AND/OR
| *Carmustine | 45.27 |
|---|---|
| Cyclophosphamide | >240 |
| Doxorubicin Hydrochloride | >240 |
| Etoposide (Toposar) | >240 |
| 5-Fluorouracil | >240 |
| Paclitaxel (Toxol) | >240 |
| Thio-Tepa | 93.50 |
| Vincristine Sulfate | >240 |
| Methotrexate | >240 |
*Caution: Testing showed an average breakthrough time of 45 minutes with Carmustine.
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Shula A. Murphy, MD
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K192327