(195 days)
A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contained a a aspossors and examiner. Tested for use with chemotherapy drugs as listed below.
Powder Free White , Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs.
This document is a 510(k) premarket notification decision letter from the FDA for surgical gloves, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and sample sizes for AI/ML device testing is not present in the provided text.
The document discusses the substantial equivalence of the "Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs" to legally marketed predicate devices. The primary performance data provided relates to the glove's resistance to permeation by chemotherapy drugs.
Here’s an attempt to structure the available information, keeping in mind the original request, but highlighting what is not applicable to this document:
1. Table of Acceptance Criteria and Reported Device Performance
For chemotherapy drug permeation, the implicit acceptance criterion is that the glove demonstrates a reasonable breakthrough detection time, particularly given the explicit note about Carmustine and Thio-Tepa having lower permeation times. The actual "acceptance criteria" for a 510(k) for this type of device would likely involve compliance with recognized standards (e.g., ASTM standards for medical gloves) which are not explicitly detailed in this letter but are implied by the regulatory review process.
| Chemotherapy Drug | Acceptance Criterion (Implicitly desirable high value) | Reported Device Performance (White Glove) | Reported Device Performance (Green Glove) |
|---|---|---|---|
| 1. Carmustine (BCNU) 3.3 mg/ml | N/A (Standard dependent) | 108.3 min | 88.2 min |
| 2. Cisplatin 1.0 mg/ml | N/A (Standard dependent) | >240 min | >240 min |
| 3. Cyclophosphamide (Cytoxan) 20mg/ml | N/A (Standard dependent) | >240 min | >240 min |
| 4. Dacarbazine (DTIC) 10.0 mg/ml | N/A (Standard dependent) | >240 min | >240 min |
| 5. Doxorubicin Hydrochloride 2.0 mg/ml | N/A (Standard dependent) | >240 min | >240 min |
| 6. Etoposide (Toposar) 20.0 mg/ml | N/A (Standard dependent) | >240 min | >240 min |
| 7. Fluorouracil 50.0 mg/ml | N/A (Standard dependent) | >240 min | >240 min |
| 8. Ifosfamide 50.0 mg/ml | N/A (Standard dependent) | >240 min | >240 min |
| 9. Methotrexate 25 mg/ml | N/A (Standard dependent) | >240 min | >240 min |
| 10. Mitomycin C 0.5 mg/ml | N/A (Standard dependent) | >240 min | >240 min |
| 11. Mitoxantrone 2.0 mg/ml | N/A (Standard dependent) | >240 min | >240 min |
| 12. Paclitaxel (Taxol) 6.0 mg/ml | N/A (Standard dependent) | >240 min | >240 min |
| 13. Thio-Tepa 10.0 mg/ml | N/A (Standard dependent) | 118.7 min | 99.4 min |
| 14. Vincristine Sulfate 1.0 mg/ml | N/A (Standard dependent) | >240 min | >240 min |
Note: The document explicitly states: "Please Note that Carmustine and Thio-Tepa have low permeation time of less than 240 minutes." This indicates that even with these lower times, the device was considered acceptable for its intended use, likely with appropriate labeling.
The following points are not applicable to this document as it pertains to the regulatory clearance of surgical gloves, not an AI/ML powered device. Therefore, there is no information in the provided text to answer these questions.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document does not pertain to AI/ML software; it is for surgical gloves. The "test set" would refer to physical glove samples and the chemicals used for permeation testing, not data for an algorithm.
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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)
- Not Applicable. Ground truth, in the context of AI/ML, refers to labels or diagnoses established by experts. For surgical glove testing, "ground truth" would relate to precise chemical permeation measurements, which are typically performed by laboratory technicians using standardized instruments, not by medical experts establishing a diagnosis.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are relevant for resolving discrepancies in expert labeling for AI/ML ground truth. This is not applicable to a physical device performance test.
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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. MRMC studies are for evaluating diagnostic performance of readers, usually in conjunction with AI. This is entirely outside the scope of surgical glove clearance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This question relates to AI algorithm performance. No algorithm is being reviewed here.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. As mentioned previously, "ground truth" for AI/ML does not apply here. For surgical gloves, the "truth" is based on physical measurement protocols for chemical permeation.
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The sample size for the training set
- Not Applicable. This refers to AI/ML model training data. No AI/ML model is involved.
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How the ground truth for the training set was established
- Not Applicable. This refers to AI/ML training data labeling. No AI/ML model is involved.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Smart Glove Corporation Sdn.Bhd Foo Pu Managing Director Lot 6487, Batu 5 3/4, Sementa, Jalan Kapar, Klang, 42100 My
Re: K180221
Trade/Device Name: Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs
Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO Dated: July 04, 2018 Received: July 16, 2018
Dear Foo Pu:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 lii III -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180221
Device Name
Powder Free White , Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs.
Indications for Use (Describe)
A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contained a a aspossors and examiner. Tested for use with chemotherapy drugs as listed below.
Chemotherapy Drug permeation ( Breakthrough Detection Time) in Minutes. The following chemicals have been tested with these gloves.
| Chemotherapy Drugs: | Breakthrough Detection Time in Minutes | |
|---|---|---|
| White Glove | Green Glove | |
| 1. Carmustine (BCNU)3.3 mg/ml(3,300 ppm) | 108.3 min | 88.2 min |
| 2. Cisplatin 1.0 mg/ml (1,000ppm) | >240 min | >240 min |
| 3. Cyclophosphamide (Cytoxan) 20mg/ml(20,000ppm) | >240 min | >240 min |
| 4. Dacarbazine (DTIC)10.0 mg/ml(10,000ppm) | >240 min | >240 min |
| 5. Doxorubicin Hydrochloride 2.0 mg/ml (2,000ppm) | >240 min | >240 min |
| 6. Etoposide (Toposar) 20.0 mg/ml (20,000ppm) | >240 min | >240 min |
| 7. Fluorouracil 50.0 mg/ml (50,000ppm) | >240 min | >240 min |
| 8. Ifosfamide 50.0 mg/ml (50,000ppm) | >240 min | >240 min |
| 9. Methotrexate 25 mg/ml (25,000ppm) | >240 min | >240 min |
| 10.Mitomycin C 0.5 mg/ml (500ppm) | >240 min | >240 min |
| 11. Mitoxantrone 2.0 mg/ml (2,000ppm) | >240 min | >240 min |
| 12. Paclitaxel (Taxol) 6.0 mg/ml (6,000ppm) | >240 min | >240 min |
| 13. Thio-Tepa 10.0 mg/ml (10,000ppm) | 118.7 min | 99.4 min |
| 14. Vincristine Sulfate 1.0 mg/ml (1,000ppm) | >240 min | >240 min |
Please Note that Carmustine and Thio-Tepa have low permeation time of less than 240 minutes .
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
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).