(242 days)
The surgeon's glove is a disposable device made of synthetic 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 disposable device made of synthetic rubber latex.
This document describes the FDA clearance for the "SensiCare PI Ortho LT Surgical Glove." The primary study referenced is for the glove's permeation resistance to chemotherapy drugs.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs, which the device was tested against. While specific thresholds for "acceptance" are not explicitly stated in this document (e.g., minimum acceptable breakthrough time), the results report the breakthrough detection time for each drug. The interpretation is that a longer breakthrough time indicates better performance.
| Chemotherapy Drug (Concentration) | Acceptance Criteria (Implicit from ASTM D6978) | Reported Device Performance (Breakthrough Detection Time) |
|---|---|---|
| Bleomycin (15 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Busulfan (6 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Carboplatin (10.0 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Carmustine (BCNU) (3.3 mg/ml) | Tested per ASTM D6978 | 25.8 minutes (25.8, 34.1, 35.4) |
| Cisplatin (1.0 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Cytarabine (100 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Dacarbazine (DTIC) (10.0 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Epirubicin (Ellence) (2 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Etoposide (Toposar) (20.0 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Fludarabine (25.0 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Fluorouracil (50.0 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Idarubicin (1.0 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Ifosfamide (50.0 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Mechlorethamine HCl (1.0 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Melphalan (5 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Methotrexate (25 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Mitomycin C (0.5mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Mitoxantrone (2.0 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Paclitaxel (Taxol) (6.0 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Paraplatin (10 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Rituximab (10 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Thiotepa (10.0 mg/ml) | Tested per ASTM D6978 | 34.6 minutes (37.5, 37.8, 34.6) |
| Vincristine Sulfate (1.0 mg/ml) | Tested per ASTM D6978 | >240 minutes |
Note: The document includes a "Warning: Do not use with Carmustine" and "Caution: Testing showed a minimum breakthrough time of 34.6 minutes with Thiotepa," indicating that for these specific drugs, the performance may not meet an assumed universal acceptance criterion for all chemotherapy drugs, or at least warrants specific precautions.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The exact sample size (number of gloves or individual test replicates for each drug) is not explicitly stated in the provided text. However, for Carmustine and Thiotepa, three individual breakthrough times are listed, suggesting at least three replicates for these specific drug tests (e.g., 25.8, 34.1, 35.4 minutes for Carmustine; 37.5, 37.8, 34.6 minutes for Thiotepa). For drugs with ">240 minutes", it's implied that the test continued for at least 240 minutes without breakthrough for all tested samples.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It is a report on device testing results.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This study involves material testing (chemical permeation through a glove), not interpretation of medical images or patient data that would require expert consensus for ground truth. The "ground truth" here is the physical breakthrough detection time measured by laboratory equipment.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is a material science test, not a subjective assessment requiring adjudication. The method is likely standardized within ASTM D6978.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, this was not an MRMC comparative effectiveness study. This type of study is for evaluating diagnostic or screening performance of an AI system, often involving human readers. The current study is an objective material property test.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense, this is a "standalone" performance test, but not in the context of an AI algorithm. It's a test of the physical characteristics of the surgical glove itself, without human intervention in the measurement of permeation. The device (glove) functions independently of human interpretation regarding its barrier properties.
7. The Type of Ground Truth Used
The ground truth used is objective laboratory measurement (breakthrough detection time) in accordance with the specified standard (ASTM D6978). This is analogous to pathology or outcomes data in a clinical context, as it's a definitive, measurable characteristic of the device.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device; therefore, there is no "training set" in the conventional sense. The glove's design and manufacturing process would be informed by material science and engineering principles, not an algorithmic training process on data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI algorithm.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 2, 2021
Medline Industries, Inc. Jennifer Mason Senior Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60030
Re: K203538
Trade/Device Name: SensiCare PI Ortho LT Surgical Glove (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: June 23, 2021 Received: June 28, 2021
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 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,
Clarence W. Murray, III, Ph.D. 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) K203538
Device Name
SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)
Indications for Use (Describe)
The surgeon's glove is a disposable device made of synthetic 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 the glove.
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes.
Bleomycin 15 mg/ml >240 minutes Busulfan 6 mg/ml >240 minutes Carboplatin 10.0 mg/ml >240 minutes Carumstine (BCNU) 3.3 mg/ml 25.8 minutes (25.8, 34.1, 35.4) 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/m1 >240 minutes Methotrexate 25 mg/ml >240 minutes Mitomycin C 0.5mg/ml >240 minutes Mitoxantrone 2.0 mg/ml >40 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 34.6 minutes (37.5, 37.8, 34.6) Vincristine Sulfate 1.0 mg/ml >240 minutes
Warning: Do not use with Carmustine
Caution: Testing showed a minimum breakthrough time of 34.6 minutes with 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).