(76 days)
The Powder Free Nitrile Examination Gloves, Blue, Test For Use With Chemotherapy Drugs and Fentary) 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs: Test Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes.
The Powder Free Nitrile Examination Gloves, White, Test For Use With Chemotherapy Drugs and Fentanyl 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
The Powder Free Nittile Examination Gloves, Black,Test For Use With Chemotherapy Drugs and Fentary 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
Not Found
This document is a 510(k) premarket notification for disposable examination gloves, not an AI/ML device. Therefore, the requested information (acceptance criteria for an AI device, sample sizes for training/test sets, expert qualifications, etc.) is not applicable here.
However, I can extract the performance data of the gloves with respect to chemotherapy drug permeation, which serves as a kind of "acceptance criteria" and the "study" that proves the device meets it for this particular medical device.
1. A table of acceptance criteria and the reported device performance:
The acceptance criterion for these gloves is their resistance to permeation by specific chemotherapy drugs and Fentanyl. The "performance" is the measured Breakthrough Detection Time (in minutes) when tested according to ASTM D6978-05 (2019). A higher breakthrough time indicates better resistance.
Powder Free Nitrile Examination Gloves (Blue)
| Test Chemotherapy Drug | Concentration | Acceptance Criteria (Conceptual) | Reported Breakthrough Detection Time in Minutes |
|---|---|---|---|
| Carmustine | 3.3 mg/ml (3,300 ppm) | (Higher is better) | 21.1 |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | (Higher is better) | >240 |
| Cyclophosphamide | 20 mg/ml (20,000 ppm) | (Higher is better) | >240 |
| Dacarbazine | 10 mg/ml (10,000 ppm) | (Higher is better) | >240 |
| Doxorubicin HCl | 2.0 mg/ml (2,000 ppm) | (Higher is better) | >240 |
| Etoposide | 20.0 mg/ml (20,000 ppm) | (Higher is better) | >240 |
| Fluorouracil | 50.0 mg/ml (50,000 ppm) | (Higher is better) | >240 |
| Mechlorethamine HCl | 1 mg/ml (1,000 ppm) | (Higher is better) | >240 |
| Methotrexate | 25.0 mg/ml (25,000 ppm) | (Higher is better) | >240 |
| Mitomycin C | 0.5 mg/ml (500 ppm) | (Higher is better) | >240 |
| Paclitaxel | 6.0 mg/ml (6,000 ppm) | (Higher is better) | >240 |
| Thio Tepa | 10.0 mg/ml (10,000 ppm) | (Higher is better) | 43.3 |
| Vincristine Sulfate | 1.0 mg/ml (1,000 ppm) | (Higher is better) | >240 |
| Fentanyl Citrate Injection | 100mcg/2ml | (Higher is better) | >240 |
Powder Free Nitrile Examination Gloves (White)
| Test Chemotherapy Drug | Concentration | Acceptance Criteria (Conceptual) | Reported Breakthrough Detection Time in Minutes |
|---|---|---|---|
| Carmustine | 3.3 mg/ml (3,300 ppm) | (Higher is better) | 11.9 |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | (Higher is better) | >240 |
| Cyclophosphamide | 20 mg/ml (20,000 ppm) | (Higher is better) | >240 |
| Dacarbazine | 10 mg/ml (10,000 ppm) | (Higher is better) | >240 |
| Doxorubicin HCl | 2.0 mg/ml (2,000 ppm) | (Higher is better) | >240 |
| Etoposide | 20.0 mg/ml (20,000 ppm) | (Higher is better) | >240 |
| Fluorouracil | 50.0 mg/ml (50,000 ppm) | (Higher is better) | >240 |
| Mechlorethamine HCl | 1 mg/ml (1,000 ppm) | (Higher is better) | >240 |
| Methotrexate | 25.0 mg/ml (25,000 ppm) | (Higher is better) | >240 |
| Mitomycin C | 0.5 mg/ml (500 ppm) | (Higher is better) | >240 |
| Paclitaxel | 6.0 mg/ml (6,000 ppm) | (Higher is better) | >240 |
| Thio Tepa | 10.0 mg/ml (10,000 ppm) | (Higher is better) | 33.0 |
| Vincristine Sulfate | 1.0 mg/ml (1,000 ppm) | (Higher is better) | >240 |
| Fentanyl Citrate Injection | 100mcg/2ml | (Higher is better) | >240 |
Powder Free Nitrile Examination Gloves (Black)
| Test Chemotherapy Drug | Concentration | Acceptance Criteria (Conceptual) | Reported Breakthrough Detection Time in Minutes |
|---|---|---|---|
| Carmustine | 3.3 mg/ml (3,300 ppm) | (Higher is better) | 11.3 |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | (Higher is better) | >240 |
| Cyclophosphamide | 20 mg/ml (20,000 ppm) | (Higher is better) | >240 |
| Dacarbazine | 10 mg/ml (10,000 ppm) | (Higher is better) | >240 |
| Doxorubicin HCl | 2.0 mg/ml (2,000 ppm) | (Higher is better) | >240 |
| Etoposide | 20.0 mg/ml (20,000 ppm) | (Higher is better) | >240 |
| Fluorouracil | 50.0 mg/ml (50,000 ppm) | (Higher is better) | >240 |
| Mechlorethamine HCl | 1 mg/ml (1,000 ppm) | (Higher is better) | >240 |
| Methotrexate | 25.0 mg/ml (25,000 ppm) | (Higher is better) | >240 |
| Mitomycin C | 0.5 mg/ml (500 ppm) | (Higher is better) | >240 |
| Paclitaxel | 6.0 mg/ml (6,000 ppm) | (Higher is better) | >240 |
| Thio Tepa | 10.0 mg/ml (10,000 ppm) | (Higher is better) | 28.7 |
| Vincristine Sulfate | 1.0 mg/ml (1,000 ppm) | (Higher is better) | >240 |
| Fentanyl Citrate Injection | 100mcg/2ml | (Higher is better) | >240 |
Note: The document explicitly states "Warning: Don't use with either Carmustine or Thiotepa" for all glove types, indicating that for these specific drugs, the breakthrough times (e.g., 11.3 - 43.3 minutes) are considered insufficient for safe use. This itself serves as an implicit "acceptance criterion" that for these two drugs no amount of permeation time would be considered acceptable for use. For the other drugs, ">240 minutes" is the reported performance, implying that the gloves withstand permeation for at least 4 hours, which is likely considered an acceptable duration for many clinical applications.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact sample size (number of gloves or tests performed per drug). It simply states that the gloves "were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs". This standard details the testing methodology, which typically involves multiple replicate tests.
- Data Provenance: The testing was done in accordance with an international standard (ASTM D6978-05), suggesting a controlled laboratory environment. The manufacturer is Zibo Lanhua Medical Packaging Material Co., Ltd, based in Zibo, Shandong, China. The testing itself would be prospective in nature, as it's specifically conducted to evaluate the performance of these new glove formulations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable to this type of device. The "ground truth" here is objective physical measurement of chemical permeation, not subjective expert assessment of medical images or patient data. The "experts" involved would be laboratory technicians or chemists experienced in conducting ASTM D6978-05, not medical specialists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used for subjective assessments (e.g., medical image interpretation) where multiple experts might disagree. Chemical permeation testing is a standardized, objective measurement.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device, nor does it involve human readers or comparative effectiveness studies in the context of diagnostic performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" is objective, laboratory-measured chemical permeation data, obtained using a standardized testing method (ASTM D6978-05). This is a direct physical measurement.
8. The sample size for the training set
Not applicable. This is a manufactured product, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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.
December 4, 2022
Zibo Lanhua Medical Packaging Material Co., Ltd Lily Wang Operation Manager No. 21 Qingtian Road, Xindian Street, Zibo, Shandong 255414 China
Re: K222815
Trade/Device Name: Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ, QDO Dated: September 13, 2022 Received: September 19, 2022
Dear Lily Wang:
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 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,
Bifeng Qian -S
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) K222815
Device Name
Powder Free Nitrile Examination Gloves, Blue, Tested For Use With Chemotherapy Drugs and Fentanyl
Indications for Use (Describe)
The Powder Free Nitrile Examination Gloves, Blue, Test For Use With Chemotherapy Drugs and Fentary) 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs: Test Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes
| Test Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| *Carmustine | 3.3 mg/ml (3,300 ppm) | 21.1 |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | >240 |
| Cyclophosphamide | 20 mg/ml(20,000 ppm) | >240 |
| Dacarbazine | 10 mg/ml(10,000 ppm) | >240 |
| Doxorubicin HCl | 2.0 mg/ml(2,000 ppm) | >240 |
| Etoposide | 20.0 mg/ml(20,000 ppm) | >240 |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | >240 |
| Mechlorethamine HCl | 1 mg/ml (1,000 ppm) | >240 |
| Methotrexate | 25.0 mg/ml(25,000 ppm) | >240 |
| Mitomycin C | 0.5 mg/ml(500 ppm) | >240 |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | >240 |
| *Thio Tepa | 10.0 mg/ml(10,000 ppm) | 43.3 |
| Vincristine Sulfate | 1.0 mg/ml(1,000 ppm) | >240 |
| Fentanyl Citrate Injection | 100mcg/2ml | >240 |
Please note that the following drugs have low permeation times: Carmustine 3.3mg/ml 21.1 Minutes Thiotepa 10.0 mg/ml 43.3 Minutes. Warning: Don't use with either Carmustine or 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."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K222815
Device Name
Powder Free Nitrile Examination Gloves, White, Test For Use With Chemotherapy Drugs and Fentanyl
Indications for Use (Describe)
| Test Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| *Carmustine | 3.3 mg/ml (3,300 ppm) | 11.9 |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | >240 |
| Cyclophosphamide | 20 mg/ml(20,000 ppm) | >240 |
| Dacarbazine | 10 mg/ml(10,000 ppm) | >240 |
| Doxorubicin HCl | 2.0 mg/ml(2,000 ppm) | >240 |
| Etoposide | 20.0 mg/ml(20,000 ppm) | >240 |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | >240 |
| Mechlorethamine HCl | 1 mg/ml (1,000 ppm) | >240 |
| Methotrexate | 25.0 mg/ml(25,000 ppm) | >240 |
| Mitomycin C | 0.5 mg/ml(500 ppm) | >240 |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | >240 |
| *Thio Tepa | 10.0 mg/ml(10,000 ppm) | 33.0 |
| Vincristine Sulfate | 1.0 mg/ml(1,000 ppm) | >240 |
| Fentanyl Citrate Injection | 100mcg/2ml | >240 |
Please note that the following drugs have low permeation times: Carmustine 3.3mg/ml 11.9 Minutes Thiotepa 10.0 mg/ml 33.0Minutes.
Warning: Don't use with either Carmustine or 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."
Form Approved: OMB No. 0910-0120
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Indications for Use
510(k) Number (if known) K222815
Device Name
Powder Free Nitrile Examination Gloves, Black, Test For Use With Chemotherapy Drugs and Fentanyl
Indications for Use (Describe)
The Powder Free Nittile Examination Gloves, Black,Test For Use With Chemotherapy Drugs and Fentary 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs: Test Chemotherany Drug Concentration Breakthrough Detection Time in Minutes
| Test Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| *Carmustine | 3.3 mg/ml (3,300 ppm) | 11.3 |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | >240 |
| Cyclophosphamide | 20 mg/ml(20,000 ppm) | >240 |
| Dacarbazine | 10 mg/ml(10,000 ppm) | >240 |
| Doxorubicin HCl | 2.0 mg/ml(2,000 ppm) | >240 |
| Etoposide | 20.0 mg/ml(20,000 ppm) | >240 |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | >240 |
| Mechlorethamine HCl | 1 mg/ml (1,000 ppm) | >240 |
| Methotrexate | 25.0 mg/ml(25,000 ppm) | >240 |
| Mitomycin C | 0.5 mg/ml(500 ppm) | >240 |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | >240 |
| *Thio Tepa | 10.0 mg/ml(10,000 ppm) | 28.7 |
| Vincristine Sulfate | 1.0 mg/ml(1,000 ppm) | >240 |
| Fentanyl Citrate Injection | 100mcg/2ml | >240 |
Please note that the following drugs have low permeation times: Carmustine 3.3mg/ml 11.3 Minutes Thiotepa 10.0 mg/ml 28.7 Minutes. Warning: Don't use with either Carmustine or 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."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
§ 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.