(130 days)
The 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.
Nitrile Exam Glove, Pre-Powdered, Color White, Blue
The provided document is a 510(k) premarket notification letter from the FDA for Nitrile Exam Gloves. This type of document is for a Class I medical device (patient examination gloves) and primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting a detailed study proving the device meets specific performance acceptance criteria through clinical trials or elaborate engineering studies typically associated with AI/ML or more complex medical devices.
The information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not part of this type of regulatory submission for a simple Class I device like examination gloves. These details are much more relevant for software as a medical device (SaMD) or devices with complex algorithms, where performance metrics like sensitivity, specificity, AUC, and their associated studies are critical.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's an attempt to address the prompt based only on the available information, noting where information is absent:
Acceptance Criteria and Device Performance for Nitrile Exam Glove
As this is a 510(k) submission for a Class I device (Nitrile Exam Glove), the "acceptance criteria" and "device performance" are primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed clinical performance metrics. The core "acceptance criteria" for a 510(k) of this nature would revolve around meeting recognized standards and established physical properties for examination gloves, which are implicitly accepted by the FDA when a substantial equivalence determination is made. The document itself does not explicitly list a table of acceptance criteria or reported device performance in the way the prompt describes for more complex devices.
The "study that proves the device meets the acceptance criteria" for this type of device typically involves bench testing to demonstrate physical properties and biocompatibility, as well as an assessment against consensus standards. The 510(k) decision letter indicates that the FDA reviewed the submission, which would have included such data, but the letter itself does not contain the detailed study results.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for Nitrile Exam Gloves) | Reported Device Performance (Implied as "Substantially Equivalent") |
|---|---|
| Sterility (if applicable) | Not explicitly stated in this letter, but reviewed in 510(k) |
| Biocompatibility | Not explicitly stated in this letter, but reviewed in 510(k) |
| Physical Properties (e.g., tensile strength, elongation, barrier integrity) | Not explicitly stated in this letter, but reviewed in 510(k) and assessed against predicate |
| Freedom from powder (if powder-free) | Pre-Powdered (as stated in product name) |
| Compliance with relevant ASTM/ISO standards | Assumed to have been demonstrated in the 510(k) submission. |
| Intended Use | "Disposal device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." |
| Material properties (e.g., Nitrile) | Nitrile (as stated in product name) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided FDA letter. For examination gloves, this would typically involve samples from manufacturing lots tested for physical properties (e.g., ASTM D412, D6319 for physical properties, ASTM F1671 for viral penetration, ISO 10993 for biocompatibility)
- Data Provenance: Not specified in the letter. The manufacturer is "Jiangsu Sunshine Plastic Products, Company, Limited" based in "China, Taiwan 251," suggesting the manufacturing and potentially some testing data may originate from these regions. The document is retrospective from the perspective of the FDA review, as it's a letter confirming a decision on a submission that has already occurred.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/not specified. For examination gloves, "ground truth" is typically established by objective physical and chemical testing against recognized standards, not by expert consensus on images or clinical assessments.
- Qualifications of Experts: Not applicable/not specified. Testing would be performed by qualified laboratory personnel following standard operating procedures.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/not specified. This method is used for resolving discrepancies in expert interpretations, common in image-based diagnostic studies. It is not relevant for the physical testing of examination gloves.
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
- MRMC Study: No. This type of study is completely irrelevant for an examination glove. These studies are used to assess the impact of AI/ML algorithms on human reader performance in diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. This is irrelevant as the device is not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For examination gloves, the "ground truth" refers to the established technical specifications and performance requirements derived from international and national standards (e.g., ASTM, ISO) for physical properties (e.g., tensile strength, elongation, leak resistance) and biocompatibility. Compliance is verified through laboratory testing as opposed to expert consensus, pathology, or outcomes data.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/not specified. This concept is relevant for AI/ML models, not for passive medical devices like gloves.
9. How the ground truth for the training set was established
- Establishing Ground Truth for Training Set: Not applicable/not specified. This is relevant for AI/ML models, not for passive medical devices like gloves.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Jiangsu Sunshine Plastic Products, Company, Limited C/O Mr. Michael Lee AcmeBiotechs Company, Limited No. 45 Minsheng Road, Danshui Town Taipei County China, Taiwan 251
AUG : 7 2010
Re: K100975
Trade/Device Name: Nitrile Exam Glove, Pre-Powdered, Color White, Blue Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: July 26, 2010 Received: August 4, 2010
Dear Mr. Lee:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Wh fo
Anthony D. Watson, B.S., M.S., M.B.A. 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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K 100975
Jiangsu Sunshine Plastic Products Co., Ltd. 510(k) Notification
Nitrile Exam Glove, Pre-Powdered, Color White, Blue
Indications for Use
AUG 1 7 2010
510(k) Number (if known):
Device Name: Nitrile Exam Glove, Pre-Powdered, Color White, Blue
Indications For Use:
The 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.
Prescription Use _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elaine S. Mayhall In Elizabeth F. Claverie
Page 1 of
(Division Sign-Off) Division of Anesthesiology, General Hospital Intection Control, Dental Devices
K100975 510(k) Number:
§ 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.