(86 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free White, Black, and Purple Examination Gloves
This is a 510(k) clearance letter for Powder Free White, Black, and Purple Nitrile Examination Gloves. The document confirms that the device is substantially equivalent to legally marketed predicate devices. This type of device (medical gloves) is subject to performance standards rather than clinical studies with acceptance criteria as envisioned in your request.
Medical gloves are "general controls" devices, meaning they are primarily regulated through performance standards defined by organizations like ASTM International. The FDA assesses adherence to these standards.
Therefore, your request for acceptance criteria and study details as typically defined for AI/software devices (e.g., sample size for test sets, expert consensus, MRMC studies, effect size of AI assistance) does not apply to this medical device.
Instead, the "acceptance criteria" for these gloves would be their compliance with recognized performance standards, for example, for physical properties, barrier integrity (e.g., freedom from holes), and biocompatibility. The "study" proving this would be laboratory testing against these standards.
However, based on the provided document, here's what can be inferred about the "acceptance criteria" in the context of general controls and performance standards applicable to examination gloves:
1. A table of acceptance criteria and the reported device performance:
This document does not contain a table of acceptance criteria or reported device performance for the gloves. For medical gloves, these details would typically be found in the manufacturer's submission which would include test reports demonstrating compliance with relevant ASTM standards (e.g., ASTM D6319-19 for Nitrile Examination Gloves). These standards specify requirements for:
- Tensile strength and elongation: To ensure durability and flexibility.
- Dimensions: Length, palm width, finger thickness.
- Barrier integrity (Freedom from holes): A critical safety aspect, often tested using an AQL (Acceptable Quality Level) for water leak testing.
- Biocompatibility: To ensure the materials are not harmful to users or patients.
- Powder content: For powder-free gloves.
The FDA's clearance letter assumes these tests have been successfully conducted and reported in the 510(k) submission.
2. Sample size used for the test set and the data provenance:
- Not Applicable in this document. The document does not provide details of specific test sample sizes or data provenance as it is an FDA clearance letter, not the study report itself. For medical gloves, sample sizes for testing (e.g., AQL for pinholes) would be determined by the relevant ASTM standard.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is not a diagnostic device where expert ground truth is established. Performance is measured against objective physical and chemical standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. See point 3.
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 AI/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI/diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Objective performance standards. For medical gloves, the "ground truth" refers to meeting the scientifically established physical and chemical properties and safety requirements outlined in recognized consensus standards (e.g., ASTM standards).
8. The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not Applicable. This is not an AI/machine learning device.
In summary: The provided document is an FDA 510(k) clearance for medical gloves. The "acceptance criteria" for such devices are their compliance with recognized performance standards, which are demonstrated through laboratory testing rather than clinical studies with human "ground truth" and reader performance evaluations as would be the case for AI-enabled diagnostic devices.
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August 11, 2023
S&S Glove Corporation Poppy Rossa QA/RA Manager Lot 4, D6 Road, Dat Do I Industrial Park Phuoc Long Tho Commune Ba Ria-Vung Tau, VN790000 Vietnam
Re: K231439
Trade/Device Name: Powder Free White, Black, and Purple Nitrile Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA Dated: April 17, 2023 Received: May 17, 2023
Dear Poppy Rossa:
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/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.
Bifeng Qian -S
Bifeng Qian, M.D., 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) K231439
Device Name
Powder Free White, Black, and Purple Examination Gloves
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
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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§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.