(213 days)
The Medline Powder-Free Nitrile Examination Glove with Aloe (tested for use with chemotherapy drugs) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
| Chemotherapy Drug | Average BDT |
|---|---|
| 5-Fluorouracil | >240 min. |
| Etoposide (Toposar) | >240 min. |
| Cyclophosphamide (Cytoxan) | >240 min. |
| Carmustine | 19.31 min. |
| Thiotepa | 26.88 min. |
| Paclitaxel (Taxol) | >240 min. |
| Doxorubicin Hydrochloride | >240 min. |
| Dacarbazine (DTIC) | >240 min. |
| Cisplatin | >240 min. |
| Ifosfamide (Ifex) | >240 min. |
| Mitoxantrone | >240 min. |
| Vincristine Sulfate | >240 min. |
WARNING: Do not use with Carmustine and Thio-Tepa.
Medline Powder-Free Nitrile Examination Glove with Aloe (Green) - Tested for use with Chemotherapy Drugs
This request is about a medical glove, not an AI/ML device, so many of the requested fields are not applicable.
Here's a breakdown of the available information regarding acceptance criteria and device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Chemotherapy Drug | Acceptance Criteria (Breakthrough Detection Time) | Reported Device Performance (Average BDT) |
|---|---|---|
| 5-Fluorouracil | Not explicitly stated, implied to be acceptable | >240 min. |
| Etoposide (Toposar) | Not explicitly stated, implied to be acceptable | >240 min. |
| Cyclophosphamide (Cytoxan) | Not explicitly stated, implied to be acceptable | >240 min. |
| Carmustine | Not explicitly stated, implied to be unacceptable | 19.31 min. |
| Thiotepa | Not explicitly stated, implied to be unacceptable | 26.88 min. |
| Paclitaxel (Taxol) | Not explicitly stated, implied to be acceptable | >240 min. |
| Doxorubicin Hydrochloride | Not explicitly stated, implied to be acceptable | >240 min. |
| Dacarbazine (DTIC) | Not explicitly stated, implied to be acceptable | >240 min. |
| Cisplatin | Not explicitly stated, implied to be acceptable | >240 min. |
| Ifosfamide (Ifex) | Not explicitly stated, implied to be acceptable | >240 min. |
| Mitoxantrone | Not explicitly stated, implied to be acceptable | >240 min. |
| Vincristine Sulfate | Not explicitly stated, implied to be acceptable | >240 min. |
Note: The document explicitly states a "WARNING: Do not use with Carmustine and Thio-Tepa," which implies that the breakthrough detection times for these two drugs (19.31 min and 26.88 min, respectively) were not considered acceptable for safe use. For the other drugs, the ">240 min" result demonstrates acceptable performance, likely exceeding an unstated minimum threshold for chemotherapy drug resistance.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document. The data is presented as "Average BDT," suggesting multiple tests were conducted for each drug, but the number of gloves or drug exposures is not given.
- Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to a physical medical device like a glove. The "ground truth" for glove performance with chemotherapy drugs is established through standardized laboratory testing protocols, not expert clinical assessment.
4. Adjudication method for the test set:
- Not applicable. As this is not an AI/ML device relying on human interpretation, there's no adjudication method in the traditional sense. The breakthrough detection times are objective measurements from laboratory tests.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device. The "standalone" performance refers to the glove's inherent resistance to chemotherapy drugs, as measured in a lab.
7. The type of ground truth used:
- Laboratory Testing Results: The ground truth is the experimentally determined "Breakthrough Detection Time (BDT)" for each chemotherapy drug when tested against the glove material. This is an objective, quantitative measurement derived from standardized testing methods (though the specific standard is not stated in this document).
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
{0}------------------------------------------------
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
Mr. Matt Clausen Regulatory Affairs Medline Industries, Incorporated One Medline Place Mundelein, Illinois 60060
OCT - 2 2009
Re: K090568
Trade/Device Name: Medline Powder-Free Nitrile Examination Glove with Aloe (Green) - Tested for use with Chemotherapy Drugs
Regulation Number: 21CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZC, LZA Dated: September 22, 2009 Received: September 23, 2009
Dear Mr. Clausen:
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. 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.
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}------------------------------------------------
Page 2 - Mr. Clausen
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance:
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Susan Runner
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
510(k) Number (if known): K090568
Device Name:
Medline Powder-Free Nitrile Examination Glove with Aloe (Green) – Tested for use with Chemotherapy Drugs
Indications For Use:
The Medline Powder-Free Nitrile Examination Glove with Aloe (tested for use with chemotherapy drugs) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
| Chemotherapy Drug | Average BDT |
|---|---|
| 5-Fluorouracil | >240 min. |
| Etoposide (Toposar) | >240 min. |
| Cyclophosphamide (Cytoxan) | >240 min. |
| Carmustine | 19.31 min. |
| Thiotepa | 26.88 min. |
| Paclitaxel (Taxol) | >240 min. |
| Doxorubicin Hydrochloride | >240 min. |
| Dacarbazine (DTIC) | >240 min. |
| Cisplatin | >240 min. |
| Ifosfamide (Ifex) | >240 min. |
| Mitoxantrone | >240 min. |
| Vincristine Sulfate | >240 min. |
WARNING: Do not use with Carmustine and Thio-Tepa.
Sheila A. Murphy, M.D.
ैं.
मुंबई को बाद में बाद में बाद में बाद में बाद में बाद में बाद में में में में में में में में में में में में में में में में में में में में में में में में में में में
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090568
Prescription Use (Part 21 CFR 801 Subpart D)
(
Over-the-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.