(98 days)
Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs is made of natural rubber intended to be worn by operating personnel to protect a surgical wound from contamination. It is also tested to be used against Chemotherapy Drugs. These gloves were tested for use with cherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs is made of natural rubber intended to be worn by operating personnel to protect a surgical wound from contamination.
Here's the analysis of the provided text regarding acceptance criteria and the study:
The provided document is an FDA 510(k) clearance letter for a medical device: "Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs".
The document does not describe a study that uses an AI/ML algorithm, nor does it involve human readers, ground truth establishment through expert consensus or pathology for a diagnostic imaging device. Instead, it describes a physical characteristic test for a surgical glove.
Therefore, many of the requested points are not applicable to this document. I will focus on what is relevant to the provided text.
This document describes the testing performed on a surgical glove to assess its permeation by chemotherapy drugs.
1. A table of acceptance criteria and the reported device performance
Based on the provided information, the acceptance criteria are not explicitly stated as quantitative thresholds for "minimum breakthrough detection time" in a formal table like in a software performance study. Instead, the performance is reported against a specific standard and then followed by a warning. The implication is that a higher breakthrough time is better.
| Chemotherapy Drug and Concentration | Acceptance Criteria (Implicit) | Reported Device Performance (Minimum Breakthrough Detection Time in Minutes) |
|---|---|---|
| Carmustine (3.3 mg/ml) | Acceptable for use (prior to warning) | 13.1 |
| Cisplatin (1.0 mg/ml) | Acceptable for use | >240 |
| Cyclophosphamide (20.0 mg/ml) | Acceptable for use | >240 |
| Dacarbazine (10.0 mg/ml) | Acceptable for use | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | Acceptable for use | >240 |
| Etoposide (20.0 mg/ml) | Acceptable for use | >240 |
| Fluorouracil (50.0 mg/ml) | Acceptable for use | >240 |
| Methotrexate (25.0 mg/ml) | Acceptable for use | >240 |
| Mitomycin C (0.5 mg/ml) | Acceptable for use | >240 |
| Paclitaxel (6.0 mg/ml) | Acceptable for use | >240 |
| Thiotepa (10.0 mg/ml) | Acceptable for use (prior to warning) | 15.7 |
| Vincristine Sulfate (1.0 mg/ml) | Acceptable for use | >240 |
Note regarding acceptance criteria: The document explicitly states: "Please note that Carmustine and Thiotepa have extremely low permeation times of 13.1 minutes and 15.7 minutes respectively. WARNING: Do Not Use With: Carmustine and Thiotepa." This implies that while the gloves were tested with these drugs, their performance was deemed insufficient for safe use, leading to a "Do Not Use" warning. Therefore, for Carmustine and Thiotepa, the implicitly accepted performance might be "not usable," despite the test results being reported. For other drugs, ">240 minutes" is the reported performance and implicitly acceptable for use.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily refers to the "Latex Powder Free Surgical Glove" as a single device type. It does not provide specifics on the sample size (e.g., number of gloves tested) for the chemotherapy drug permeation test.
The testing method referenced is ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. This is a standardized, laboratory-based physical test.
The data provenance is not explicitly stated in terms of country of origin but is from the manufacturer's testing to support the 510(k) submission. This is a prospective test in the sense that the testing was performed specifically to evaluate the device against this standard.
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 is not applicable. This is a physical test of a device's barrier properties, not a diagnostic or AI/ML study requiring expert ground truth establishment. The "ground truth" is determined by the objective measurement of breakthrough time according to the ASTM standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are relevant for human-interpreted data, such as medical image analysis, not for standardized physical property testing of a 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
This is not applicable. This is a physical product, not an AI/ML algorithm or a diagnostic device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an algorithm. The "standalone performance" here would be the glove's permeation resistance under the specified test conditions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this test is established by the objective measurement of chemical permeation through the glove material using a standardized laboratory method (ASTM D6978-05). It is not based on expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This is not applicable. There is no AI/ML algorithm involved, and therefore no training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 2, 2020
Hartalega SDN BHD % Dave Yungvirt Official Correspondent Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K201748
Trade/Device Name: Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs Regulation Number: 21 CFR 878.4460 Regulation Name: Non-powdered surgeon's glove Regulatory Class: Class I, reserved Product Code: KGO, LZC Dated: September 28, 2020 Received: October 1, 2020
Dear Dave Yungvirt:
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.
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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 mediation-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,
For: Elizabeth F. Claverie-Williams, MS 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K201748
Device Name
Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs is made of natural rubber intended to be worn by operating personnel to protect a surgical wound from contamination. It is also tested to be used against Chemotherapy Drugs.
These gloves were tested for use with cherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (3.3 mg/ml) | 13.1 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Dacarbazine (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Paclitaxel (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 15.7 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that Carmustine and Thiotepa have extremely low permeation times of 13.1 minutes and 15.7 minutes respectively.
| WARNING: Do Not Use With: Carmustine and Thiotepa | |
|---|---|
| Type of Use (Select one or both, as applicable) | |
| ☐ Prescription Use (Part 21 CFR 801 Subpart D) | ☑ Over-The-Counter Use (21 CFR 801 Subpart C) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED |
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FORM FDA 3881 (7/17)
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).