(98 days)
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.
Powder Free Nitrile Examination Glove (Blue). This Product Does Not Contain Thiuram, and/or Carbamate and/or Thiazole. Low Dermatitis Potential Tested For Use With Chemotherapy Drugs.
The provided text describes a 510(k) premarket notification for a medical device: "Powder Free Nitrile Examination Glove (Blue), This Product Does Not Contain Thiuram, and/or Carbamate and/or Thiazole, Low Dermatitis Potential, Tested for Use With Chemotherapy Drugs."
This document is a regulatory clearance letter and does not contain the acceptance criteria or a study description in the format of a typical scientific or clinical study. It refers to the device's substantial equivalence to legally marketed predicate devices and mentions that the glove "has been tested for use with specific chemotherapy drugs."
However, based on the information provided, we can infer some details related to acceptance criteria and performance for the chemotherapy drug permeation testing, which is a specific claim for this device.
Here's an attempt to structure the available information per your request, recognizing the limitations of the source document:
1. Table of Acceptance Criteria and Reported Device Performance (Chemotherapy Drug Permeation)
The "Indications for Use" section lists specific chemotherapy drugs and their "Average Breakthrough Detection Time in Minutes." While not explicitly stated as "acceptance criteria," the listed times for each drug represent the performance achieved, and for most, a ">240 minute" breakthrough time is implied as a desirable (and likely passed) threshold for safe use. The specific values obtained for each drug would be the "reported device performance."
| Chemotherapy Drug | Acceptance Criteria (Implied) | Reported Device Performance (Average Breakthrough Detection Time in Minutes) |
|---|---|---|
| Dacarbazine (DTIC) | >240 minutes | >240 |
| Cyclophosphamide (Cytoxan) | Sufficiently High (e.g., >60 minutes for some standards) | 69.59 |
| Doxorubicin Hydrochloride | >240 minutes | >240 |
| 5-Fluorouracil | >240 minutes | >240 |
| Cisplatin | >240 minutes | >240 |
| Etoposide | >240 minutes | >240 |
| Paclitaxel (Taxol) | >240 minutes | >240 |
Note: The document explicitly states "Warning: Do Not Use With Thiotepa or Carmustine," indicating that the device did not meet acceptance criteria for these specific drugs or was not tested for them in a way that would deem it safe.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in this regulatory letter. For permeation testing, this typically involves multiple glove samples tested per drug.
- Data Provenance: Not explicitly stated (e.g., country of origin). The applicant, Smart Glove Corporation Sdn. Bhd., is based in MALAYSIA. It's common for testing to be conducted in a laboratory setting, which could be in various locations. The data is retrospective relative to the submission date of the 510(k).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical device performance test (chemotherapy drug permeation), not a diagnostic or interpretative study requiring human experts for ground truth establishment. The "ground truth" is determined by laboratory testing methods (e.g., spectrophotometry or chromatography to detect drug breakthrough).
4. Adjudication method for the test set
- Not Applicable. As this is a laboratory performance test, there isn't a need for expert adjudication in the same way there would be for a clinical diagnostic study. Measurements are typically objective based on standardized test methods.
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 a physical device (glove) and not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical device. Standalone algorithm performance refers to AI systems without human intervention, which is not relevant here.
7. The type of ground truth used
- Laboratory Testing / Standardized Test Methods: The "ground truth" for the chemotherapy drug permeation testing would be the objective measurement of drug breakthrough time through the glove material. This is established by specific, standardized laboratory protocols, likely following methods like ASTM D6978 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs).
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of this physical device performance testing. Training sets are relevant for machine learning or AI models.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not applicable.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 7 2009
Mr. Foo Khon Pu Smart Glove Corporation Sdn. Bhd. Lot 6487. Batu 5¾, Sementa, Jalan Kapar 42100 Klang, Selangor Darul Ehsan, MALAYSIA
Re: K091147
Trade/Device Name: Powder Free Nitrile Examination Glove (Blue), This Product Does Not Contain Thiuram, and/or Carbamate and/or Thiazole, Low Dermatitis Potential, Tested for Use With Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: July 1, 2009 Received: July 6, 2009
Dear Mr. Pu:
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.
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Page 2- Mr. Pu
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Anthony D. Winterton
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
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Indications for Use
510(k) Number (if known): K091147
Device Name:
Powder Free Nitrile Examination Glove (Blue). This Product Does Not Contain Thiuram, and/or Carbamate and/or Thias Frougtt
Low Dogmetition R. Thiuram, and/or Thiazole. Low Dermatitis Potential Tested For Use With Chemotherapy Drugs.
Indication For Use:
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.
Chemotherapy Drug Permeation (Average Breakthrough Detection Time in Minutes)
| Dacarbazine (DTIC) | >240 |
|---|---|
| Cyclophosphamide (Cytoxan) | 69.59 |
| Doxorubicin Hydrochloride | >240 |
| 5-Fluorouracil | >240 |
| Cisplatin | >240 |
| Etoposide | >240 |
| Paclitaxel (taxol) | >240 |
Warning: Do Not Use With Thiotepa or Carmustine
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Of Device Evaluation (ODE)
Shila A. Murphy, M.D.
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of __
510(k) Number: K091147
§ 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.