(76 days)
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Not Found
No
The device description and performance studies focus on the physical properties and standards compliance of a medical glove, with no mention of AI or ML technology.
No
The device is a medical glove intended to prevent contamination and is for examination/protective use, not for treating a disease or condition.
No
Explanation: The device is a medical glove, which is used to prevent contamination and for handling chemotherapy drugs. Its purpose is protective, not diagnostic.
No
The device is a physical medical glove, not a software application. The description focuses on material properties and physical standards.
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 device is a medical glove worn on the hands to prevent contamination and for handling chemotherapy drugs. This is a barrier device for personal protection and handling, not for diagnosing a condition or analyzing a sample from the human body.
- Device Description: The description focuses on the physical properties and standards met by the glove (dimensions, physical properties, freedom from holes, powder content, biocompatibility). These are characteristics of a physical barrier device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information. The device's function is purely protective and for handling.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This glove does not perform any such function.
N/A
Intended Use / 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 for use in handling chemotherapy drugs.
Product codes
LZA
Device Description
Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) meet all of the requirements of ASTM D 6319-00a(2005).
Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) meet all of the current specifications of ASTM D6319-00a(2005), Standard Specification for Nitrile Examination Gloves for Medical Application.
Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) are 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.
Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) are summarized with the following technological characteristics compared to ASTM or equivalent standards.
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
The performance test data of the non-clinical tests are the same as mentioned immediately above.
Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process.
Key Metrics
Not Found
Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Ansell
X082457
510(k) SUMMARY [1]
- Ansell Healthcare Products LLC (2) 1635 Industrial Road Dothan, AL 36303
NOV 1 0 2008
Lon D. McIlvain, Vice President Regulatory and Quality Affairs Global Contact: (334) 615-2562 Telephone: (334) 615-2568 Fax:
February 26, 2008
- Trade Name: Micro-Touch® NitraTexTM Sterile Nitrile Powder-Free Blue [3] Examination Gloves (Chemotherapy Use)
Common Name: Examination Gloves
Classification Name: Glove, Patient Examination, Nitrile
- Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves [4] (Chemotherapy Use) meet all of the requirements of ASTM D 6319-00a(2005).
- Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves િરો (Chemotherapy Use) meet all of the current specifications of ASTM D6319-00a(2005), Standard Specification for Nitrile Examination Gloves for Medical Application.
- Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves (୧) (Chemotherapy Use) are 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.
- Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves [7] (Chemotherapy Use) are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standard |
|---|---|
| Dimensions | Meets ASTM D 6319-00a(2005) |
| Physical Properties | Meets ASTM D 6319-00a(2005) |
| Freedom from Holes | Meets ASTM D 6319-00a(2005) |
| Meets ASTM D 5151-06 | |
| Powder-Free | Powder content ≤ 2 mg per glove |
| Biocompatibility: | |
| ISO Skin Irritation Study | |
| ISO Maximization Sensitization Study - Extract | No irritation |
| No irritation |
1
- [8] The performance test data of the non-clinical tests are the same as mentioned immediately above.
- Clinical data is not needed for medical gloves or for most devices cleared by the [9] 510(k) process.
- [10] It is concluded that Micro-Touch® NitraTexTM Sterile Nitrile Powder-Free Blue 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.
- [1] This summary will include any other information reasonably deemed necessary by the FDA.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Cynthia A. Ingram Regulatory Affairs Manager Ansell Healthcare Products, LLC 1635 Industrial Road Dothan, Alabama 36303
NOV 1 0 2008
Re: K082457
Trade/Device Name: Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: October 20, 2008 Received: October 21, 2008
Dear Ms. Ingram:
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 such 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 - Ms. Ingram
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Suite H. Melvin Oms FOR DR CHIU HN
Chiu S. Lin, Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(K) Number (if known):
Device Name:
Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use)
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 for use in handling chemotherapy drugs.
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH Office of Device Evaluation (ODE)
Shudy R. Murphy, MD
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082457