(76 days)
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No
The document describes examination gloves and their testing for chemotherapy drug permeation, with no mention of AI or ML technology.
No
The device, examination gloves, is intended to prevent contamination between patient and examiner, not to provide therapy or treatment for a condition.
No
The device is described as an examination glove intended to prevent contamination, not to diagnose or provide diagnostic information.
No
The device described is a physical product (examination gloves) and does not involve any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Intended Use: The intended use of these gloves is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier device for personal protection.
- Testing Performed: While the gloves are tested for permeation by chemotherapy drugs and fentanyl, this testing is related to the protective barrier function of the glove, not to diagnose or provide information about a patient's health status from a sample.
The testing for chemotherapy drug and fentanyl permeation is a performance characteristic of the glove as a protective barrier, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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:
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:
Product codes
LZA, LZC, OPJ, QDO
Device Description
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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
hand or finger
Indicated Patient Age Range
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Intended User / Care Setting
Examiner (medical purposes)
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 devices 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 and Fentanyl Citrate Injection.
- Powder Free Nitrile Examination Gloves, Blue:
- Carmustine (3.3 mg/ml): 21.1 minutes
- Cisplatin (1.0 mg/ml): >240 minutes
- Cyclophosphamide (20 mg/ml): >240 minutes
- Dacarbazine (10 mg/ml): >240 minutes
- Doxorubicin HCl (2.0 mg/ml): >240 minutes
- Etoposide (20.0 mg/ml): >240 minutes
- Fluorouracil (50.0 mg/ml): >240 minutes
- Mechlorethamine HCl (1 mg/ml): >240 minutes
- Methotrexate (25.0 mg/ml): >240 minutes
- Mitomycin C (0.5 mg/ml): >240 minutes
- Paclitaxel (6.0 mg/ml): >240 minutes
- Thio Tepa (10.0 mg/ml): 43.3 minutes
- Vincristine Sulfate (1.0 mg/ml): >240 minutes
- Fentanyl Citrate Injection (100mcg/2ml): >240 minutes
- Powder Free Nitrile Examination Gloves, White:
- Carmustine (3.3 mg/ml): 11.9 minutes
- Cisplatin (1.0 mg/ml): >240 minutes
- Cyclophosphamide (20 mg/ml): >240 minutes
- Dacarbazine (10 mg/ml): >240 minutes
- Doxorubicin HCl (2.0 mg/ml): >240 minutes
- Etoposide (20.0 mg/ml): >240 minutes
- Fluorouracil (50.0 mg/ml): >240 minutes
- Mechlorethamine HCl (1 mg/ml): >240 minutes
- Methotrexate (25.0 mg/ml): >240 minutes
- Mitomycin C (0.5 mg/ml): >240 minutes
- Paclitaxel (6.0 mg/ml): >240 minutes
- Thio Tepa (10.0 mg/ml): 33.0 minutes
- Vincristine Sulfate (1.0 mg/ml): >240 minutes
- Fentanyl Citrate Injection (100mcg/2ml): >240 minutes
- Powder Free Nitrile Examination Gloves, Black:
- Carmustine (3.3 mg/ml): 11.3 minutes
- Cisplatin (1.0 mg/ml): >240 minutes
- Cyclophosphamide (20 mg/ml): >240 minutes
- Dacarbazine (10 mg/ml): >240 minutes
- Doxorubicin HCl (2.0 mg/ml): >240 minutes
- Etoposide (20.0 mg/ml): >240 minutes
- Fluorouracil (50.0 mg/ml): >240 minutes
- Mechlorethamine HCl (1 mg/ml): >240 minutes
- Methotrexate (25.0 mg/ml): >240 minutes
- Mitomycin C (0.5 mg/ml): >240 minutes
- Paclitaxel (6.0 mg/ml): >240 minutes
- Thio Tepa (10.0 mg/ml): 28.7 minutes
- Vincristine Sulfate (1.0 mg/ml): >240 minutes
- Fentanyl Citrate Injection (100mcg/2ml): >240 minutes
Key Metrics
Breakthrough Detection Time in Minutes for various chemotherapy drugs and Fentanyl Citrate Injection.
Low permeation times for Carmustine and Thiotepa were noted for all three glove colors.
Predicate Device(s)
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Reference Device(s)
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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
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.
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,
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
2
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.
3
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
Image /page/3/Picture/21 description: The image contains text that reads "PSC Publishing Services (301) 443-6740". The text appears to be a company name and phone number. There are also the letters "EF" on the right side of the image.
4
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.