(115 days)
Not Found
Not Found
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 technologies.
No
The device, disposable medical nitrile examination gloves, is intended to prevent contamination and protect the examiner from chemotherapy drugs, not to treat a disease or medical condition in a patient.
No
Explanation: The device is described as disposable medical nitrile examination gloves intended to prevent contamination and protect against chemotherapy drugs. Its purpose is to provide a barrier, not to diagnose any medical condition.
No
The device description clearly states it is "Disposable Medical Nitrile Examination Gloves," which are a physical hardware product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is to prevent contamination between patient and examiner by being worn on the hand. This is a barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: It's described as "Disposable Medical Nitrile Examination Gloves." This aligns with a barrier device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition. The testing mentioned is for the glove's barrier properties against chemotherapy drugs, which is a performance characteristic of the device itself, not a diagnostic test.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
This device is intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with the following chemotherapy drug concentrations per ASTM 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 drug has low permeation times of less than 60 minutes:
Carmustine (BCNU) 3.3 mg/ml (3.300 ppm), 23.9minutes
ThioTepa10.0 mg/ml (10,000 ppm),25.3 minutes
WARNING: Do not use 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): 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.
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 28, 2022
Anhui Xinyisheng Medical Technology Co., Ltd % Johnson Liu Consultant Cnmed Consulting 31 Archer St Upper Mount Gravatt, QLD 4122 Australia
Re: K213325
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: September 29, 2021 Received: October 5, 2021
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 medical devices and radiation-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.
Clarence W. Murray, III, PhD 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)
K213325
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 examiner's hand to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with the following chemotherapy drug concentrations per ASTM 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 drug has low permeation times of less than 60 minutes:
Carmustine (BCNU) 3.3 mg/ml (3.300 ppm), 23.9minutes
ThioTepa10.0 mg/ml (10,000 ppm),25.3 minutes
WARNING: Do not use Carmustine and Thiotepa
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) | X |
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."