(134 days)
The Eudermic MP Powder-Free Latex Examination Glove (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.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device, specifically examination gloves. It does not contain information about an AI/ML powered device, acceptance criteria or a study proving that an AI/ML powered device meets acceptance criteria. The only performance data included is for the gloves' resistance to chemotherapy drugs. Therefore most of the requested fields cannot be filled.
Below is the information that can be extracted or deduced from the provided text, primarily regarding the glove's performance against chemotherapy drugs.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Breakthrough Detection Time (BDT) for 5-Fluorouracil | >240 min. |
| Breakthrough Detection Time (BDT) for Etoposide (Toposar) | >240 min. |
| Breakthrough Detection Time (BDT) for Cyclophosphamide (Cytoxan) | >240 min. |
| Breakthrough Detection Time (BDT) for Carmustine | 6.26 min. |
| Breakthrough Detection Time (BDT) for Thiotepa | 12.13 min. |
| Breakthrough Detection Time (BDT) for Paclitaxel (Taxol) | >240 min. |
| Breakthrough Detection Time (BDT) for Doxorubicin Hydrochloride | >240 min. |
| Breakthrough Detection Time (BDT) for Dacarbazine (DTIC) | >240 min. |
| Breakthrough Detection Time (BDT) for Cisplatin | >240 min. |
| Breakthrough Detection Time (BDT) for Ifosfamide (Ifex) | >240 min. |
| Breakthrough Detection Time (BDT) for Mitoxantrone | >240 min. |
| Breakthrough Detection Time (BDT) for Vincristine Sulfate | >240 min. |
| Protein Content Label Claim | <50 ug/dm² per glove of extractable protein |
Note: The document provides reported performance values but does not explicitly state the acceptance criteria (i.e., minimum acceptable BDT). However, the values themselves implicitly represent the performance achieved to gain clearance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes a regulatory clearance for examination gloves and mentions results from testing with chemotherapy drugs, but does not detail the methodology of these tests, including sample size or data provenance.
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 information is not applicable to this document. The document pertains to physical examination gloves, not an AI/ML device that requires human expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to this document for the reasons stated above.
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
This is not applicable as the document is not about an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the document is not about an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the chemotherapy drug testing, the "ground truth" would be the direct measurement of drug breakthrough time, likely determined by standardized laboratory testing methods (e.g., ASTM standards for permeation testing). For protein content, it would be laboratory measurement of extractable protein. These are objective laboratory measurements, not expert consensus or pathology in the context of an AI/ML device.
8. The sample size for the training set
This information is not provided and is not applicable to this type of device. The document describes examination gloves, which do not have a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
This information is not provided and is not applicable to this type of device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Matt Clausen Regulatory Affairs Specialist Medline Industries, Incorporated One Medline Place Mundelein, Illinois 60060-4486
APR 2 1 2511
Re: K103602
Trade/Device Name: Eudermic MP Powder-Free Latex Examination Glove (Blue), Tested for Use with Chemotherapy Drugs, with a Protein Content Label Claim <50ug/dm2 Per Glove of Extractable Protein Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: 1 Product Code: LYY, LZC Dated: April 15, 2011 Received: April 18, 2011
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. 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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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/AboutliDA/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 vours
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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Indications for Use
510(k) Number (if known):
Device Name: K 103602
Eudermic MP Powder-Free Latex Examination Glove (blue), Tested for use with Eudermic Mr 1 owder-Free Eates Enaiment label claim <50μg/dm² per glove of extractable protein.
Indications For Use:
The Eudermic MP Powder-Free Latex Examination Glove (tested for use with chemotherapy I lie Luderillic MF Torract From 2017 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 | 6.26 min. |
| Thiotepa | 12.13 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. |
Please note that the following drugs have extremely low permeation times:
- Carmustine 6.26 minutes �
- Thiotepa 12.13 minutes .
(Division Sign-Off), Jours 2 2 mar 20 0 1 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: = 103 602/500 2
Prescription Use (Part 21 CFR 801 Subpart D) OR
X 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)
§ 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.