(110 days)
Not Found
Not Found
No
The 510(k) summary describes a medical glove and its testing against chemical permeation, with no mention of AI or ML technology.
No.
The device is described as an examination glove intended to prevent contamination, not to treat a medical condition.
No
Explanation: This device is a medical glove, designed to prevent contamination between patient and examiner. Its purpose is protective, not diagnostic, as it does not gather or interpret data to identify a disease or condition.
No
The device description clearly states it is a "Dual Color Blue/White Powder Free Nitrile Examination Glove," which is a physical hardware product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hand or finger. This is a barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: It's a glove, a physical barrier.
- 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 certain substances, not for diagnosing anything.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not fit that description.
N/A
Intended Use / Indications for Use
A Powder Free 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 for use with chemotherapy drug and Fentanyl Test Claim. In addition these gloves were tested for use with Chemotherapy drug and Fentanyl Citrate Tested claim in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by Chemotherapy drug and Fentanyl Citrate Tested Claim.
Chemotherapy Drugs and Concentration:
- Carmustine (BCNU) 3.3mg/ml - Minimum Breakthrough Detection Time(Min), ug/cm2/minute: 28.8 minutes
- Cyclophosphamide (Cytoxan) (20mg/ml) - Minimum Breakthrough Detection Time(Min), ug/cm2/minute: >240 minutes
- Cytarabine HCI (100mg/ml) - Minimum Breakthrough Detection Time(Min), ug/cm2/minute: >240 minutes
- Doxorubicin HCI (2.0mg/ml) - Minimum Breakthrough Detection Time(Min), ug/cm2/minute: >240 minutes
- Etoposide (20.0mg/ml - Minimum Breakthrough Detection Time(Min), ug/cm2/minute: >240 minutes
- Fluorouracil (50.0mg/ml) - Minimum Breakthrough Detection Time(Min), ug/cm2/minute: >240 minutes
- Methotrexate (25mg/ml) - Minimum Breakthrough Detection Time(Min), ug/cm2/minute: >240 minutes
- Paclitaxel (6.0mg/ml) - Minimum Breakthrough Detection Time(Min), ug/cm2/minute: >240 minutes
- ThioTepa (10.0mg/ml) - Minimum Breakthrough Detection Time(Min), ug/cm2/minute: 57.6 minutes
- Fentanyl Citrate Injection 100mg/2ml - Minimum Breakthrough Detection Time(Min), ug/cm2/minute: >240 minute
The Maximum testing time is 240 minutes. Please note that the following drugs have extremely low Permeation time, Carmustine (BSNU) 3.3mg/ml Thio Tepa (10.0mg/ml) WARNING: Not for use with Carmustine or Thio Tepa Tested for use with Chemotherapy Drugs using ASTM D6978-05. Gloves used for protection against chemotherapy drug exposure must be selected specifically for the type of drugs being used.
Product codes
LZA, LZC, ODO
Device Description
Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim
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
Not Found
Key Metrics
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.
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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 & 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.
July 19, 2022
ECO Medi Glove Sdn.Bhd. Suresh Kumar OA Manager Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate Taiping, Perak Darul Ridzuan 34600 Malaysia
Re: K220943
Trade/Device Name: Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, ODO Dated: May 31, 2022 Received: June 10, 2022
Dear Suresh Kumar:
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.
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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. 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K220943
Device Name
Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim
Indications for Use (Describe)
A Powder Free 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 for use with chemotherapy drug and Fentanyl Test Claim. In addition these gloves were tested for use with Chemotherapy drug and Fentanyl Citrate Tested claim in accordance with ASTM D6978-05 standards
Practice for assessment of Medical Glove to Permeation by Chemotherapy drug and Fentanyl Citrate Tested Claim.
| Chemotherapy Drugs and Concentration | Minimum Breakthrough Detection Time(Min), ug/cm2/minute |
|---|---|
| 1) Carmustine (BCNU) 3.3mg/ml | 28.8 minutes |
| 2) Cyclophosphamide (Cytoxan) (20mg/ml) | >240 minutes |
| 3) Cytarabine HCI (100mg/ml) | >240 minutes |
| 4) Doxorubicin HCI (2.0mg/ml) | >240 minutes |
| 5) Etoposide (20.0mg/ml | >240 minutes |
| 6) Fluorouracil (50.0mg/ml) | >240 minutes |
| 7) Methotrexate (25mg/ml) | >240 minutes |
| 8) Paclitaxel (6.0mg/ml) | >240 minutes |
| 9) ThioTepa (10.0mg/ml) | 57.6 minutes |
| 10) Fentanyl Citrate Injection 100mg/2ml | >240 minute |
The Maximum testing time is 240 minutes. Please note that the following drugs have extremely low Permeation time, Carmustine (BSNU) 3.3mg/ml Thio Tepa (10.0mg/ml)
WARNING: Not for use with Carmustine or Thio Tepa Tested for use with Chemotherapy Drugs using ASTM D6978-05. Gloves used for protection against chemotherapy drug exposure must be selected specifically for the type of drugs being used.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
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