(20 days)
A powderfree patient examination glove is a disposable device made of natural rubber latex or synthetic material that is intended to be worn on the hand or fingers for medical purposes to provide a barrier against poetentially infectious and other contaminants.
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This document is a 510(k) premarket notification FDA letter for examination gloves. As such, it does not contain the detailed information required to describe the acceptance criteria and the study proving a device meets those criteria in the way envisioned by the prompt (which is more typical for AI/software as a medical device).
However, I can extract the information that is present and explain why other requested information is not available in this type of document.
Here's an analysis based on the provided text, addressing the points you requested:
Acceptance Criteria and Device Performance for Shanghai Huamao Powder-Free Yellow Vinyl Examination Gloves (K024154)
This 510(k) premarket notification primarily focuses on establishing "substantial equivalence" of the Shanghai Huamao Powder-Free Yellow Vinyl Examination Gloves to predicate devices. For medical devices like gloves, "acceptance criteria" and "device performance" in a 510(k) context generally refer to meeting recognized standards (e.g., ASTM standards for physical properties, biocompatibility, etc.) and demonstrating that the new device is as safe and effective as a legally marketed predicate. The provided text does not include a table of specific acceptance criteria or detailed performance data from testing. The FDA letter states: "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...". This implies that the manufacturer provided data in their full submission that demonstrated compliance with relevant performance standards, but this detailed data is not part of this summary FDA letter.
Here's what can be inferred or stated about the requested points:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Inferred): For examination gloves, acceptance criteria typically involve meeting established ASTM standards for properties such as tensile strength, elongation, puncture resistance, barrier integrity (freedom from holes), and biocompatibility. The specific thresholds for these would be defined in those standards. The document does not explicitly list these criteria or values.
- Reported Device Performance: The document states that the device was found "substantially equivalent" to predicate devices. This implies that the submitted performance data met the necessary standards, but the actual performance values are not reported in this letter.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not available in the provided FDA letter. The 510(k) summary (or full submission) would contain details on test methods, sample sizes, and data provenance.
- The manufacturer is "Shanghai Huamao Gloves Company Limited" in "Shanghai, China," implying the manufacturing origin, but not necessarily the origin of the performance test data.
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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):
- This concept is typically relevant for interpretative devices (e.g., AI for medical imaging) where human expert consensus defines the "ground truth." For a physical device like an examination glove, "ground truth" is established through objective, standardized physical and chemical testing (e.g., tensile testing, leak testing, biocompatibility assays). Therefore, the concept of "experts establishing ground truth" in the sense of clinical interpretation does not apply here.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Similar to point 3, adjudication methods are used to resolve discrepancies in expert interpretations. Since "ground truth" for gloves is based on objective measurements against standards, adjudication methods are not applicable in this context.
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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:
- MRMC studies are specific to evaluating interpretive devices, often AI-powered, by comparing human reader performance with and without AI assistance. This device is a physical examination glove, not an interpretive device or AI. Therefore, an MRMC study was not performed and is not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This refers to the performance of an algorithm without human intervention, again relevant for AI/software devices. Since this is a physical medical glove and not an algorithm, a standalone performance study in this sense was not done and is not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For examination gloves, the "ground truth" for performance is based on objective measurements against recognized national and international standards for physical properties (e.g., strength, durability, barrier integrity), biocompatibility (e.g., cytotoxicity, irritation, sensitization), and other relevant properties. There is no "pathology" or "outcomes data" in the typical clinical sense for establishing the fundamental performance of the glove itself.
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The sample size for the training set:
- This concept is relevant for machine learning algorithms that require large datasets for training. As this is a physical examination glove, and not an AI/ML device, there is no "training set" in this context.
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How the ground truth for the training set was established:
- As there is no training set for a physical device like an examination glove, this question is not applicable.
Summary of what the document implies about the study for these gloves:
The FDA's determination of "substantial equivalence" means that Shanghai Huamao Gloves Company Limited provided data (in their full 510(k) submission, not shown here) demonstrating that their Powder-Free Yellow Vinyl Examination Gloves meet the same safety and effectiveness criteria as existing, legally marketed predicate gloves. This typically involves:
- Physical testing (e.g., tensile properties, freedom from holes) to relevant ASTM or ISO standards.
- Biocompatibility testing to ISO 10993 standards (e.g., cytotoxicity, irritation, sensitization).
- Labeling compliance.
- Material composition comparison with predicate devices.
The FDA letter itself is a regulatory confirmation, not a detailed scientific study report.
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Image /page/0/Picture/2 description: The image is a black and white circular logo for the Department of Health & Human Services USA. The logo features the department's name encircling a stylized emblem. The emblem consists of a symbol that resembles a stylized human form or a caduceus, which is a symbol associated with healthcare.
FEB 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shanghai Huamao Gloves Company Limited C/O Ms. Susan D. Goldstein-Falk MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
Re: K024154
Trade/Device Name: Shanghai Huamao Powder-Free Yellow Vinyl Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: September 9, 2002 Received: December 17, 2002
Dear Ms. Falk:
This letter corrects our substantially equivalent letter of September 9, 2002, regarding the device name.
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Ms. Falk
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runner
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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No.8 NEW INDUSTRIAL AREA, ZHU HANG ZHEN, JINSHAN COUNTY, SHANGHAI, CHINA
C/O Room C, No:201 Nanking East Rd., Sec 3, Taipei, Taiwan,
Tel:886-2-25462480 Fax:886-2-2712-5051
August 30th 2002
INDICATIONS FOR USE
Applicant: Shanghai Huamao Gloves Co., Ltd
24154 510(k) Number (if known):*
Device Name: Shanghai Huamao Gloves Co., Ltd Pouder-Free Yellow Vinyl Eyamination Glove.
Indications For Use: A powderfree patient examination glove is a disposable device made of natural rubber latex or synthetic material that is intended to be worn on the hand or fingers for medical purposes to provide a barrier against poetentially infectious and other contaminants.
Sincerely
Haich l Shich
Hsieh Yi Shi
Shanghai Huamao Gloves Co., Ltd
(Please refer to Attachment #3)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR Over-The-Counter
Per 21 CRF 801.109
(Optional Format 11-2-96)
- For a new submission, do NOT fill in the 510(k) number.
Qlin S. Lin
510(k) Number: K024154
§ 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.