(147 days)
A powder-free latex 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.
Colored Powder Free Latex Examination Glove (White and Blue) Tested With Chemotherapy Drugs With A Protein Claim Of Less Than 50ug/dm2
The provided text is a clearance letter from the FDA for a medical device: "Colored Powder Free Latex Examination Glove (White and Blue) Tested With Chemotherapy Drugs With A Protein Claim Of Less Than 50ug/dm-".
This document does not describe an AI/ML powered device or a study with acceptance criteria and performance as would be expected for such a device. Instead, it's a 510(k) premarket notification clearance letter for a patient examination glove. The "study" mentioned within the document relates to the glove's resistance to chemotherapy drugs.
Therefore, the requested information elements related to AI/ML device performance (like sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance) are not applicable to this document.
However, I can extract information related to the performance claims made for the glove regarding chemotherapy drug resistance.
Here's the relevant information that can be extracted:
1. A table of acceptance criteria and the reported device performance
The document presents the breakthrough detection time (BDT) for various chemotherapy drugs when tested with the gloves. While explicit "acceptance criteria" for BDT are not stated in this document (it's often referenced against national or international standards, which are not detailed here), the reported performance is the BDT in minutes. The implication is that a longer BDT is better.
| Chemotherapy Drugs | White Latex Powder Free Average BDT (min) | Blue Latex Powder Free Average BDT (min) |
|---|---|---|
| Carmustine (BCNU) 3.3mg/ml | 15.2 | 5.7 |
| Cisplatin 1.0mg/ml | >240 | >240 |
| Cyclophosphamide (Cytoxan) 20.0mg/ml | >240 | >240 |
| Dacarbazine (DTIC) 10.0mg/ml | >240 | >240 |
| Doxorubicin Hydrochloride 2.0 mg/ml | >240 | >240 |
| Etoposide (Toposar) 20.0 mg/ml | >240 | >240 |
| Fluorouracil 50.0 mg/ml | >240 | >240 |
| Ifosfamide 50.0 mg/ml | >240 | >240 |
| Methotrexate 25.0 mg/ml | >240 | >240 |
| Mitomycin C 0.5 mg/ml | >240 | >240 |
| Mitoxantrone 2.0 mg/ml | >240 | >240 |
| Paclitaxel (Taxol) 6.0 mg/ml | >240 | >240 |
| Thiothepa 10.0 mg/ml | 15.2 | 16.4 |
| Vincristine Sulfate 1.0 mg/ml | >240 | >240 |
Note: The document also explicitly highlights:
- White Latex Powder Free: Carmustine - 15.2 minutes, Thiotepa - 15.2 Minutes
- Blue Latex Powder Free: Carmustine - 5.7 minutes, Thiotepa - 16.4 minutes
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: Not specified in the provided text for the chemotherapy drug resistance testing.
- Data Provenance: Not specified in the provided text. The manufacturer is based in Malaysia. The testing data would typically be generated in a lab.
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)
- Not applicable. This is not an AI/ML device requiring expert ground truth in the diagnostic sense. The "ground truth" for glove performance is determined by laboratory testing protocols for chemical resistance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not an AI/ML device.
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 not an AI/ML device. The "device performance" relies on physical testing against chemicals.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the chemotherapy drug resistance is established through laboratory testing methodologies that measure the time it takes for a chemical to permeate the glove material (Breakthrough Detection Time). This is a direct physical measurement, not an expert assessment of a medical condition.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Tekmedic (M) Sdn Bhd Mr. Patrick Leong Chief Operation Officer Plot 4, Tanjung Kling Industrial Area Tanjung Bruas Jetty, Tanjung Kling Malacca, Malaysia 76400
Re: K121594
Trade/Device Name: Colored Powder Free Latex Examination Glove (White and Blue) Tested With Chemotherapy Drugs With A Protein Claim Of Less Than 50ug/dm-
Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY, LZC Dated: October 18, 2012 Received: October 22, 2012
Dear Mr. Leong:
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. 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.
OCT 25 2012
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Page 2- Mr. Leong
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,
Anthony D. Watson, B.S., M.S., M.B.A.
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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Premarket Notification For Colored Powder Free Latex Examination Glove (White And Blue) Tested With Chemotherapy Drugs with A Protein Claim Of Less Than 50μg/Dm2
Indication For Use Statement · 4.0
K121594 510 (K) Number (if known) : ___
Device Name :
Colored Powder Free Latex Examination Glove (White and Blue) Tested With Chemotherapy Drugs With A Protein Claim Of Less Than 50ug/dm2
Indication For Use
A powder-free latex 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.
The tested chemotherapy drugs and their breakthrough detection time are as follows :
White Latex Powder Free
Blue Latex Powder.Free
| Chemotherapy Drugs | Average BDT |
|---|---|
| Carmustine (BCNU) 3.3mg/ml | 15.2 |
| Cisplatin 1.0mg/ml | >240 min |
| Cyclophosphamide (Cytoxan) 20.0mg/ml | >240 min |
| Dacarbazine (DTIC) 10.0mg/ml | >240 min |
| Doxorubicin Hydrochloride 2.0 mg/ml | >240 min |
| Etoposide ( Toposar) 20.0 mg/ml | >240 min |
| Fluorouracil 50.0 mg/ml | >240 min |
| Ifosfamide 50.0 mg/ml | >240 min |
| Methotrexate 25.0 mg/ml | >240 min |
| Mitomycin C 0.5 mg/ml | >240 min |
| Mitoxantrone 2.0 mg/ml | >240 min |
| Paclitaxel (Taxol) 6.0 mg/ml | >240 min |
| Thiothepa 10.0 mg/ml | 15.2 |
| Vincristine Sulfate 1.0 mg/ml | >240 min |
Please note that the following drugs have extremely low permeation times:
-
Carmustine - 15.2 minutes
-
Thiotepa - 15.2 Minutes
Prescription Use Part 21 CFR 801 Subpart D
A verage Chemotherapy Drugs BDT Carmustine (BCNU) 3.3mg/ml 5.7 >240 min Cisplatin 1.0mg/ml >240 min Cyclophosphamide (Cytoxan) 20.0mg/ml >240 min Dacarbazine (DTIC) 10.0mg/ml Doxorubicin Hydrochloride 2.0 >240 min mg/ml >240 min Etoposide ( Toposar) 20.0 mg/ml >240 min Fluorouracil 50.0 mg/ml Ifosfamide 50.0 mg/ml >240 min >240 min Methotrexate 25.0 mg/ml >240 min Mitomycin C 0.5 mg/ml Mitoxantrone 2.0 mg/ml >240 min Paclitaxel (Taxol) 6.0 mg/ml >240 min 16.4 Thiothepa 10.0 mg/ml >240 min Vincristine Sulfate 1.0 mg/ml
Please note that the following drugs have extremely low permeation times:
-
Carmustine - 5.7 minutes
-
Thiotepa - 16.4 minutes
X Over-The-Counter Use (21 CFR 801 Subpart C)
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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.