(81 days)
Not Found
NOT APPLICABLE
No
The device description and performance studies focus on the material properties and chemical resistance of examination gloves, with no mention of AI or ML.
No
This device is described as "Disposable Medical Nitrile Examination Gloves" and is intended for protection during examinations, not for therapeutic purposes.
No
Explanation: The device is described as "Disposable Medical Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs," which are protective barriers and not used for diagnosing medical conditions.
No
The device description clearly states it is "Disposable Medical Nitrile Examination Gloves," which are a physical hardware product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside the body (in vitro) to diagnose, monitor, or screen for diseases or conditions.
- Device Description and Intended Use: The description clearly states this device is a "Disposable Medical Nitrile Examination Glove" intended to be "worn on the examination between patient and examiner." Its primary function is to provide a barrier for protection during medical examinations, particularly when handling certain chemotherapy drugs.
- Lack of Specimen Analysis: The device does not analyze any biological specimens from the patient. It is a physical barrier.
- Focus on Barrier Properties: The performance studies focus on the glove's ability to resist permeation by chemotherapy drugs, which is a measure of its barrier function, not its diagnostic capability.
Therefore, based on the provided information, this device is a medical glove used for protection and is not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This device is intended for medical purpose that is worn on the examination between patient and examiner. In addition, these examination gloves were tested for use with the following chemotherapy drug concentrations per ASTN D6978-05(2019):
The following drugs had NO breakthrough detected up to 240 minutes:
Cisplatin, 1.0 mg/ml (1,000 ppm)
Cyclophosphamide (Cytoxan),20.0 mg/ml (20,000 ppm)
Dacarbazine, 10.0 mg/ml (10,000 ppm)
Doxorubicin HCI, 2.0 mg/ml (2,000 ppm)
Etoposide, 20.0 mg/ml (20,000 ppm)
Fluorouracil, 50.0 mg/ml (50,000 ppm)
Paclitaxel, 6.0 mg/ml (6,000 ppm)
Please note that the following drugs have low permeation times of less than 240 minutes: Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 34.4minutes ThioTepa10.0 mg/ml (10,000 ppm),88.5 minutes
WARNING: Do not use with Carmustine and Thiotepa
Product codes
LZA, LZC
Device Description
Not Found
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
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
May 14, 2022
Hainan Asther Medical Equipment Co., Ltd % Johnson Liu Consultant CNMed Consulting 31 Archer St Upper Mount Gravatt, QLD 4122 Australia
Re: K220491
Trade/Device Name: Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: February 14, 2022 Received: February 22, 2022
Dear Johnson Liu:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Bifeng Qian, M.D., Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
This device is intended for medical purpose that is worn on the examination between patient and examiner. In addition, these examination gloves were tested for use with the following chemotherapy drug concentrations per ASTN D6978-05(2019):
The following drugs had NO breakthrough detected up to 240 minutes:
| Cisplatin, 1.0 mg/ml (1,000 ppm) |
|---|
| Cyclophosphamide (Cytoxan),20.0 mg/ml (20,000 ppm) |
| Dacarbazine, 10.0 mg/ml (10,000 ppm) |
| Doxorubicin HCI, 2.0 mg/ml (2,000 ppm) |
| Etoposide, 20.0 mg/ml (20,000 ppm) |
| Fluorouracil, 50.0 mg/ml (50,000 ppm) |
| Paclitaxel, 6.0 mg/ml (6,000 ppm) |
Please note that the following drugs have low permeation times of less than 240 minutes: Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 34.4minutes ThioTepa10.0 mg/ml (10,000 ppm),88.5 minutes
WARNING: Do not use with Carmustine and Thiotepa
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."