(96 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 for surgical gloves, not a study report for an AI/ML device. Therefore, it does not contain the information required to answer the questions about acceptance criteria and study details for an AI/ML device.
Specifically, the document discusses:
- The trade name and regulation of "Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove".
- The FDA's determination of substantial equivalence for this medical device.
- The "Indications for Use" for the gloves, particularly their testing for use with chemotherapy drugs based on ASTM D6978.
- Breakthrough times for various chemotherapy drugs when tested with "Signature Latex" and "Signature Latex Micro" gloves.
- Warnings against using the gloves with Carmustine and Thiotepa due to short breakthrough times.
There is no mention of any AI/ML components, acceptance criteria for an AI/ML algorithm, or details of a study proving such a device meets specific performance criteria.
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Medline Industries, Inc. Jennifer Mason Senior Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093
Re: K202668
Trade/Device Name: Signature Latex and Signature Latex Micro, 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: November 24, 2020 Received: November 25, 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
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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: 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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Indications for Use
510(k) Number (if known)
K202668
Device Name
Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs 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.
Signature Latex
Bleomycin (15 mg/ml) >240 minutes Busulfan (6 mg/ml) >240 minutes Carboplatin (10.0 mg/ml) >240 minutes Carmustine (3.0 mg/ml) 12.6 minutes (12.6, 13.1, 12.7) 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
Signature Latex Micro
Bleomycin (15 mg/ml) >240 minutes Busulfan (6 mg/ml) >240 minutes Carboplatin (10.0 mg/ml)>240 minutes Carmustine (3.0 mg/ml) 11.4 minutes (12.0, 11.4, 12.5)
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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) 12.7 minutes (13.8, 13.1, 12.7) 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).