(84 days)
The surgeon's glove is a device made of natural rubber latex intended to be worn by surgeon's and or operating room personnel to protect a surgical wound from contamination. In addition these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The surgeon's glove is a device made of natural rubber latex intended to be worn by surgeon's and or operating room personnel to protect a surgical wound from contamination.
This document is a 510(k) clearance letter from the FDA for a surgical glove, specifically the "Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm2 per Glove of Extractable Protein" manufactured by Medline Industries, Inc.
The information provided describes the performance of a physical medical device (surgical gloves) against chemical permeation, not the performance of an AI/ML algorithm. Therefore, many of the requested details, such as MRMC studies, ground truth establishment by experts, training set sample sizes, and AI-specific metrics, are not applicable to this document.
However, I can extract the acceptance criteria and reported performance for the surgical gloves based on the provided table.
Acceptance Criteria and Device Performance for Surgical Gloves
The acceptance criteria for these surgical gloves, specifically regarding their resistance to chemotherapy drug permeation, are implicitly defined by the reported breakthrough times based on ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The device is considered to meet the acceptance criteria if it demonstrates a certain level of resistance (measured in minutes before permeation) for various chemotherapy drugs.
Here’s a table summarizing the acceptance criteria (implied by the test results) and the reported device performance:
| Chemotherapy Drug (Concentration) | Acceptance Criteria (Minimum Breakthrough Time) | Reported Device Performance (Breakthrough Time) |
|---|---|---|
| Bleomycin (15 mg/ml) | >240 minutes (implied) | >240 minutes |
| Busulfan (6 mg/ml) | >240 minutes (implied) | >240 minutes |
| Carboplatin (10.0 mg/ml) | >240 minutes (implied) | >240 minutes |
| Carmustine (3.0 mg/ml) | Not specified as a minimum; result reported | 12.0 minutes (13.2, 12.9, 12.0) |
| Cisplatin (1.0 mg/ml) | >240 minutes (implied) | >240 minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 minutes (implied) | >240 minutes |
| Cytarabine 100 mg/ml | >240 minutes (implied) | >240 minutes |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 minutes (implied) | >240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 minutes (implied) | >240 minutes |
| Epirubicin (Ellence) (2 mg/ml) | >240 minutes (implied) | >240 minutes |
| Etoposide (Toposar) (20.0 mg/ml) | >240 minutes (implied) | >240 minutes |
| Fludarabine (25.0 mg/ml) | >240 minutes (implied) | >240 minutes |
| Fluorouracil (50.0 mg/ml) | >240 minutes (implied) | >240 minutes |
| Idarubicin (1.0 mg/ml) | >240 minutes (implied) | >240 minutes |
| Ifosfamide (50.0 mg/ml) | >240 minutes (implied) | >240 minutes |
| Mechlorethamine HCI (1.0 mg.ml) | >240 minutes (implied) | >240 minutes |
| Melphalan (5 mg/ml) | >240 minutes (implied) | >240 minutes |
| Methotrexate (25 mg/ml) | >240 minutes (implied) | >240 minutes |
| Mitomycin C (0.5 mg/ml) | >240 minutes (implied) | >240 minutes |
| Mitoxantrone (2.0 mg/ml) | >240 minutes (implied) | >240 minutes |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 minutes (implied) | >240 minutes |
| Paraplatin (10 mg/ml) | >240 minutes (implied) | >240 minutes |
| Rituximab (10 mg/ml) | >240 minutes (implied) | >240 minutes |
| Thiotepa (10.0 mg/ml) | Not specified as a minimum; result reported | 22.4 minutes (22.6, 22.4, 23.1) |
| Vincristine Sulfate (1.0 mg/ml) | >240 minutes (implied) | >240 minutes |
Note: For Carmustine and Thiotepa, while specific long resistance times were not achieved, the measured breakthrough times are presented. The "Warning: Do not use with Carmustine and Thiotepa" statement indicates that these drugs did not meet the desired long-duration protection, and this limitation is explicitly communicated in the labeling.
Non-Applicable Information (due to the nature of the device)
The following points are not applicable to the provided document, as it pertains to a physical medical device (surgical gloves) and not an AI/ML diagnostic or assistive device:
- Sample size used for the test set and the data provenance: The document doesn't specify the exact number of gloves tested for each chemical. The "data provenance" refers to the origin of clinical data, which is not relevant here. The testing is likely done prospectively in a lab setting according to the ASTM standard.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth for chemical permeation is established by standardized laboratory testing methods (ASTM D6978), not by human experts interpreting clinical images or data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for laboratory testing of physical properties.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: MRMC studies are used for evaluating diagnostic performance of human readers, often with and without AI assistance. This is not relevant for glove permeation testing.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: "Standalone" refers to an AI algorithm's performance. Not applicable here.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for glove performance is the direct measurement of chemical permeation according to the ASTM standard.
- The sample size for the training set: Not applicable. There is no AI/ML algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable for the same reason.
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November 18, 2020
Medline Industries, Inc. Jennifer Mason Senior Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093
Re: K202449
Trade/Device Name: Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50ug/dm2 per glove of Extractable Protein Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I. reserved Product Code: KGO, LZC Dated: August 24, 2020 Received: August 26, 2020
Dear Jennifer Mason:
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 medical devices and radiation-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: CAPT Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202449
Device Name
Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with a Protein Content Label Claim of <50µg/dm2 per Glove of Extractable Protein
Indications for Use (Describe)
The surgeon's glove is a device made of natural rubber latex intended to be worn by surgeon's and or operating room personnel to protect a surgical wound from contamination. In addition these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The following chemicals have been tested with these gloves.
| Bleomycin (15 mg/ml) | >240 minutes |
|---|---|
| Busulfan (6 mg/ml) | >240 minutes |
| Carboplatin (10.0 mg/ml) | >240 minutes |
| Carmustine (3.0 mg/ml) | 12.0 minutes (13.2, 12.9, 12.0) |
| Cisplatin (1.0 mg/ml) | >240 minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 minutes |
| Cytarabine 100 mg/ml | >240 minutes |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 minutes |
| Epirubicin (Ellence) (2 mg/ml) | >240 minutes |
| Etoposide (Toposar) (20.0 mg/ml) | >240 minutes |
| Fludarabine (25.0 mg/ml) | >240 minutes |
| Fluorouracil (50.0 mg/ml) | >240 minutes |
| Idarubicin (1.0 mg/ml) | >240 minutes |
| Ifosfamide (50.0 mg/ml) | >240 minutes |
| Mechlorethamine HCI (1.0 mg.ml) | >240 minutes |
| Melphalan (5 mg/ml) | >240 minutes |
| Methotrexate (25 mg/ml) | >240 minutes |
| Mitomycin C (0.5 mg/ml) | >240 minutes |
| Mitoxantrone (2.0 mg/ml) | >240 minutes |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 minutes |
| Paraplatin (10 mg/ml) | >240 minutes |
| Rituximab (10 mg/ml) | >240 minutes |
| Thiotepa (10.0 mg/ml) | 22.4 minutes (22.6, 22.4, 23.1) |
| Vincristine Sulfate (1.0 mg/ml) | >240 minutes |
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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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).