(150 days)
Latex Powder Free Surgical Glove with Protein Labeling 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 chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
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This document is a 510(k) premarket notification from the FDA, specifically for a Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs.
The request asks for information typically found in an AI/Software as a Medical Device (SaMD) study, such as acceptance criteria, sample sizes for training and testing, expert qualifications, and MRMC studies. However, this document describes a physical medical device (surgical gloves), not an AI/SaMD.
Therefore, I cannot provide the requested information because it is not applicable to the provided document. The document details the device's intended use and performance against chemotherapy drugs, but it does not involve any AI/ML components or studies of human-in-the-loop performance with AI.
To directly answer your questions based on the provided document:
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A table of acceptance criteria and the reported device performance:
The acceptance criteria for chemotherapy drug permeation are implicitly defined by the "Minimum Breakthrough Detection Time in Minutes" columns, and the reported device performance is the value in that column. The standard used is ASTM D6978-05 (Reapproved 2019):- Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes (Acceptance Criteria & Reported Performance)
- Carmustine (BCNU) (3.3 mg/ml) | 12.5
- Cisplatin (1 mg/ml) | > 240
- Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240
- Dacarbazine (10 mg/ml) | > 240
- Doxorubicin HCI (2.0 mg/ml) | > 240
- Etoposide (20.0 mg/ml) | > 240
- Fluorouracil (50.0 mg/ml) | > 240
- Methotrexate (25 mg/ml) | > 240
- Mitomycin C (0.5 mg/ml) | > 240
- Paclitaxel (6.0 mg/ml) | > 240
- Thiotepa (10.0 mg/ml) | 13.6
- Vincristine Sulfate (1.0 mg/ml) | > 240
- Note: The document also explicitly warns against using the gloves with Carmustine (BCNU) and Thiotepa due to low permeation times.
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Sample sizes used for the test set and the data provenance: Not applicable to this type of device. The testing methodology for ASTM D6978-05 would define the sample sizes for glove permeation testing, but this is not detailed in the FDA letter. Data provenance would be from laboratory testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device performance is established through standardized laboratory testing, not human expert consensus.
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Adjudication method: Not applicable.
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If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is for AI/SaMD, not physical gloves.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used: Laboratory test results based on ASTM D6978-05 for chemotherapy drug permeation and potentially other standards for protein labeling claims.
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The sample size for the training set: Not applicable. This is a manufactured product, not an AI model.
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How the ground truth for the training set was established: Not applicable.
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May 26, 2022
Hartalega NGC SDN. BHD. Nurul Kong Deputy General Manager-Quality Assurance No. 1 Persiaran Tanjung Sepang, Kawasan Perindustrian Tanjung 43900 Malaysia
Re: K214074
Trade/Device Name: Latex Powder Free Surgical Glove with Protein Labeling 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: April 8, 2022 Received: April 14, 2022
Dear Nurul Kong:
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.
Bifeng Qian, M.D., Ph.D. Acting 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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Indications for Use
510(k) Number (if known) K214074
Device Name
Latex Powder Free Surgical Glove with Protein Labeling 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 Labeling 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 chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 12.5 |
| Cisplatin (1 mg/ml) | > 240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 |
| Dacarbazine (10 mg/ml) | > 240 |
| Doxorubicin HCI (2.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Methotrexate (25 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Paclitaxel (6.0 mg/ml) | > 240 |
| Thiotepa (10.0 mg/ml) | 13.6 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
Please note that the following drugs have low permeation times: Carmusiine (BCNU) 3.3 mg/ml 12.5 minutes; Thiotepa 10.0 mg/ml 13.6 minutes. Warning: Please do not use with Carmustine (BCNU) 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)
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§ 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).