(112 days)
Powder Free Surgical gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy:
| Test Chemotherapy Drug (Concentration) | Minimum Breakthrough Detection Time in minutes |
|---|---|
| Fluorouracil (50.0mg/ml) | >240 |
| Etoposide (20.0mg/ml) | >240 |
| Cyclophosphamide (20.0mg/ml) | >240 |
| Carmustine (3.3mg/ml) | 22.0 |
| Thiotepa (10.0mg/ml) | 24.2 |
| Paclitaxel (6.0mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0mg/ml) | >240 |
| Methotrexate (25.0mg/ml) | >240 |
| Vincristine Sulfate (1.0mg/ml) | >24 |
"WARNING: Do not use with Carmustine and Thiotepa"
Not Found
The provided text describes the FDA's 510(k) clearance for "ENCORE Latex Ortho" and "GAMMEX Latex Ortho" powder-free latex surgical gloves. This document is a clearance letter for a medical device (surgical gloves), not a study report for an AI/CADeX device. As such, it does not contain the information requested in your prompt regarding acceptance criteria and studies that prove the device meets those criteria in the context of AI/CADeX devices.
The document primarily focuses on:
- Substantial equivalence to legally marketed predicate devices.
- General controls provisions for medical devices.
- Indications for Use for the surgical gloves, which includes their testing for use with chemotherapy drugs as per ASTM D6978.
However, based on the provided text, I can extract the acceptance criteria related to chemotherapy drug permeation for these gloves as a device performance specification.
Here's the closest I can get to fulfilling your request based only on the provided text, reinterpreting the "device" as the surgical gloves and the "study" as the chemotherapy drug permeation testing:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Chemotherapy Drug (Concentration) | Acceptance Criteria (Minimum Breakthrough Detection Time in minutes) | Reported Device Performance (Breakthrough Detection Time in minutes) |
|---|---|---|
| Fluorouracil (50.0mg/ml) | >240 | >240 |
| Etoposide (20.0mg/ml) | >240 | >240 |
| Cyclophosphamide (20.0mg/ml) | >240 | >240 |
| Carmustine (3.3mg/ml) | Not for use (implied acceptance is failure) | 22.0 |
| Thiotepa (10.0mg/ml) | Not for use (implied acceptance is failure) | 24.2 |
| Paclitaxel (6.0mg/ml) | >240 | >240 |
| Doxorubicin Hydrochloride (2.0mg/ml) | >240 | >240 |
| Methotrexate (25.0mg/ml) | >240 | >240 |
| Vincristine Sulfate (1.0mg/ml) | >24 (Based on common interpretation of similar data, implying >=24) | >24 |
Note: The "acceptance criteria" where the device is "Not for use" (e.g., Carmustine, Thiotepa) implies that the breakthrough time observed (22.0 and 24.2 minutes respectively) was not considered adequate for safe use with these specific drugs, leading to the warning statement. For other drugs, the reported performance meets or exceeds the implicit acceptance criteria (i.e., ">240" meets ">240").
Regarding the remaining points (2-9), this information is NOT available in the provided text as it pertains to AI/CADeX device studies, not the clearance of surgical gloves.
- 2. Sample size used for the test set and the data provenance: Not applicable. The text describes testing of physical gloves against chemotherapy drugs, not a data-driven AI model.
- 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for glove permeation is established by laboratory measurement using a standard (ASTM D6978).
- 4. Adjudication method: Not applicable.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- 7. The type of ground truth used: For chemotherapy permeation, the ground truth is objective laboratory measurement according to ASTM D6978.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
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June 24, 2021
Careplus (M) SDN BHD Lim Shyan CEO/Managing Director Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate Seremban, Negeri Sembilan 70450 Malaysia
Re: K210656
Trade/Device Name: ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 ug/dm2 per glove of total aqueous extractable protein) 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 Dated: May 25, 2021 Received: May 27, 2021
Dear Lim Shyan:
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.
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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 801 and Part 809 ); medical device reporting (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 (OS) 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 Clarence W. Murray III. 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
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Indications for Use
510(k) Number K210656
Device Name
GAMMEX® Latex Ortho, Powder free Latex Surgical Gloves with Protein Content Labeling Claim (< 50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs. ENCORE® Latex Ortho, Powder free Latex Surgical Gloves with Protein Content Labeling Claim (< 50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs
Indications for Use (Describe)
Powder Free Surgical gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy:
| Test Chemotherapy Drug (Concentration) | Minimum Breakthrough Detection Time inminutes |
|---|---|
| Fluorouracil (50.0mg/ml) | >240 |
| Etoposide (20.0mg/ml) | >240 |
| Cyclophosphamide (20.0mg/ml) | >240 |
| Carmustine (3.3mg/ml) | 22.0 |
| Thiotepa (10.0mg/ml) | 24.2 |
| Paclitaxel (6.0mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0mg/ml) | >240 |
| Methotrexate (25.0mg/ml) | >240 |
| Vincristine Sulfate (1.0mg/ml) | >24 |
"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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Department of Health and Human Services
Food and Drug Administration
§ 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).