(137 days)
The surgeons glove is a disposable device made of synthetic rubber intended to be worn by 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 surgeons glove is a disposable device made of synthetic rubber.
The provided document is a 510(k) clearance letter for SensiCare PI and SensiCare PI Micro Surgical Gloves. It details the device classification, regulatory information, and, importantly, the "Indications for Use" which includes a section on chemotherapy drug permeation. This section contains the acceptance criteria and the results of the study proving the device meets these criteria.
Here's an analysis of the provided information:
Acceptance Criteria and Reported Device Performance
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by the standard ASTM D6978, which is a "Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs." The performance is measured by the "Breakthrough Detection Time" in minutes. While the document does not explicitly state a minimum breakthrough time as an acceptance criterion for all chemotherapy drugs, it presents the breakthrough times for each drug. The fact that the gloves are indicated for use with these drugs (except where warnings are given) implies that the reported breakthrough times meet an acceptable threshold within the context of the ASTM D6978 standard for medical gloves.
For drugs with reported breakthrough times of 240 minutes, this indicates that no permeation was detected within the 240-minute test period. For drugs with shorter breakthrough times, the specific times are given. The warnings for Carmustine and Thiotepa for both glove types due to shorter breakthrough times also imply that extended permeation resistance is an implicit acceptance criterion for safe use with these drugs.
| Chemotherapy Drug (Concentration) | SensiCare PI Breakthrough Detection Time (minutes) | SensiCare PI Micro Breakthrough Detection Time (minutes) | Acceptance Criteria (Implicit from ASTM D6978 & Warning) |
|---|---|---|---|
| Bleomycin (15 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Busulfan (6 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Carboplatin (10.0 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Carmustine (3.3 mg/ml) | 12.4 (12.4, 14.4, 12.4) | 12.4 (13.1, 13.8, 12.4) | Warning: Do not use (Low resistance) |
| Cisplatin (1.0 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Cyclophosphamide (20 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Dacarbazine (10.0 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Doxorubicin HCl (2.0 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Epirubicin (2 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Etoposide (20.0 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Fludarabine (25.0 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Fluorouracil (50.0 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Idarubicin (1.0 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Ifosfamide (50.0 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Mechlorethamine HCl (1.0 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Melphalan (5 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Methotrexate (25 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Mitomycin (0.5 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Mitoxantrone (2.0 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Paclitaxel (6.0 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Paraplatin (10 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Rituximab (10 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Thiotepa (10.0 mg/ml) | 12.4 (12.4, 13.4, 13.2) | 22.3 (22.3, 23.9, 23.2) | Warning: Do not use (Low resistance) |
| Vincristine Sulfate (1.0 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
Study Details
The document refers to a specific study type: "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." This indicates that the study adhered to this established standard.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document provides breakthrough times, and for Carmustine and Thiotepa, it explicitly lists three individual breakthrough times (e.g., 12.4, 14.4, 12.4). This suggests that at least three samples were tested for these specific drugs for each glove type. For the drugs with a 240-minute breakthrough time, the document does not specify the number of samples, but ASTM D6978 generally requires testing of multiple specimens (e.g., typically at least three) to ensure representative results.
- Data Provenance: The document does not specify the country of origin of the data. The study appears to be a prospective evaluation of the glove's performance against the specified standard, as it's a test performed on the device to prove its properties.
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 type of study (chemical permeation testing) does not typically involve human experts in the way that image interpretation or clinical outcomes studies do. The "ground truth" is established by the standardized laboratory methodology and instrumentation used to detect chemical permeation as defined by ASTM D6978. There are no human expert readers or clinicians involved in establishing the ground truth for chemical breakthrough time.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this study is a laboratory-based chemical permeation test, not a subjective assessment requiring adjudication among experts. The results are objective measurements of breakthrough time. When multiple values are provided (e.g., for Carmustine and Thiotepa), they represent individual test replicates, not adjudicated interpretations.
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 MRMC study. It's a laboratory test of a physical device's chemical resistance properties, not an evaluation of human reader performance or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device being tested in a laboratory, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" is defined by the objective measurement of chemical permeation according to the ASTM D6978 standard. This involves analytical techniques to detect the breakthrough of chemotherapy drugs through the glove material over time. It is not based on expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Not applicable. This is a physical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. Since there is no training set, this question is not relevant.
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April 6, 2020
Medline Industries, Inc. Jennifer Mason Senior Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093
Re: K193217
Trade/Device Name: SensiCare PI and SensiCare PI Micro Surgical Gloves Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO, LZC Dated: March 6, 2020 Received: March 10, 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.
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
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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,
Image /page/1/Picture/5 description: The image shows the FDA logo. The letters "FDA" are in a large, light blue font. To the right of the letters, there is some text that is cut off. The image is simple and clean.
Elizabeth F. Claverie -S
CAPT Elizabeth Claverie, M.S. 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) K193217
Device Name
SensiCare PI and SensiCare PI Micro Surgical Gloves
Indications for Use (Describe)
The surgeons glove is a disposable device made of synthetic rubber intended to be worn by 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.
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes
SensiCare PI
Bleomycin (15 mg/ml) 240 minutes Busulfan (6 mg/ml) 240 minutes Carboplatin (10.0 mg/ml) 240 minutes Carmustine (3.3 mg/ml) 12.4 minutes (12.4, 14.4, 12.4) Cisplatin (1.0 mg/ml) 240 minutes Cyclophosphamide (Cytoxan) (20 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 (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) 12.4 minutes (12.4, 13.4, 13.2) Vincristine Sulfate (1.0 mg/ml) 240 minutes
Warning: Do not use with Carmustine and Thiotepa
SensiCare PI Micro
Bleomycin 15 mg/ML 240 minutes Busulfan 6 mg/ml 240 minutes Carboplatin 10.0 mg/ml 240 minutes
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Carmustine (BCNU) 3.3 mg/ml 12.4 (13.1, 13.8, 12.4) minutes Cisplatin 1.0 mg/ml 240 minutes Cyclophosphamide (Cytoxan) 20 mg/ml 240 minutes Dacarbazine (DTIC) 10.0 mg/ml 240 minutes Doxorubicin Hydrochloride 2.0 mg/ml Epirubicin (Ellence) 2 mg/ml Etoposide (Toposar) 20.0 mg/ml 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 10.0 mg/ml 240 minutes Rituximab 10 mg/ml 240 minutes Thiotepa 10.0 mg/ml 22.3 (22.3, 23.9, 23.2) minutes 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)
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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).