(35 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.
The device is powdered Nitrile Exam Gloves. They are non-sterile, single use, disposable gloves.
The provided document is a 510(k) summary for a Nitrile Examination Glove. It details the safety and effectiveness of the device as required for FDA clearance. The information you're asking for, acceptance criteria and study details related to a device performance study that proves the device meets the criteria, is present in the document.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present a table with explicit "acceptance criteria" alongside "reported device performance" in a structured side-by-side manner. However, it lists the standards and tests performed, implying that the acceptance criteria are embedded within these standards, and the reported performance is that the device "met and/or exceeded the requirements."
Here's an interpretation based on the provided text:
| Acceptance Criteria (Implied by Standard/Test) | Reported Device Performance |
|---|---|
| Requirements of ASTM D3578-95 | Met and/or exceeded |
| Primary Skin Irritation Study | Met and/or exceeded |
| Dermal Sensitization Study | Met and/or exceeded |
| FDA Water Leak (AQL 1.5) before aging | Met and/or exceeded |
| FDA Water Leak (AQL 1.5) after aging | Met and/or exceeded |
Note: The document explicitly states: "The device has met and/or exceeded the requirements of the following standards and laboratory tests." This indicates positive performance against the implicit acceptance criteria of these standards.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the sample sizes used for each of the listed tests (e.g., for ASTM D3578-95, Primary Skin Irritation Study, Dermal Sensitization Study, or FDA Water Leak tests). These would typically be defined by the specific ASTM standards or FDA guidelines referenced.
- Data Provenance: The document does not specify the country of origin of the data. It mentions that "All tests were performed in a certified testing laboratory," but does not name the laboratory's location or whether the data was retrospective or prospective. It is highly likely to be prospective testing specifically conducted for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable to this type of device and study. The "device" in question is a nitrile examination glove. The performance evaluation is based on objective physical, chemical, and biological tests (e.g., ASTM standards, skin irritation tests, water leak tests), not on human expert interpretation of data or images where "ground truth" would be established by experts.
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers interpret medical images or data and their performance needs to be assessed against a consensus ground truth. The tests for a medical glove are objective laboratory measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This section is not applicable. An MRMC study is relevant for diagnostic medical devices where multiple human readers assess cases with and without AI assistance. This document describes the performance of a physical medical device (examination glove) based on standardized laboratory tests, not a diagnostic AI system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This section is not applicable. This question refers to the performance of an AI algorithm in isolation. The document describes a physical medical device and its performance is evaluated through physical, chemical, and biological tests, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance of the nitrile examination glove is established by:
- Standards: The requirements defined in ASTM D3578-95.
- Laboratory Test Outcomes: Objective results from "Primary Skin Irritation Study," "Dermal Sensitization Study," and "FDA Water Leak" tests, which have defined pass/fail criteria. These are empirical, measurable standards, not expert consensus or pathology in the context of diagnostic devices.
8. The Sample Size for the Training Set
This section is not applicable. The device is a physical product (nitrile examination glove), not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as point 8.
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Image /page/0/Picture/0 description: The image shows a sequence of handwritten alphanumeric characters. The sequence starts with the letter 'K', followed by the number '9', another '9', the number '1', the number '8', the number '2', and ends with the number '1'. The characters are written in a simple, slightly uneven style.
- 1 1999 JUL
27 JANNA TUCKER & ASSOCIATES
| 198 Avenue De La D'emerald | |||
|---|---|---|---|
| 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS | Sparks, NV 89434-9550Ph: 775-342-2612Fax: 775-342-2613 | ||
| NINGBO YUJIANG PLASTIC & RUBBER CO., LTDNITRILE EXAMINATION GLOVE, POWDERED | |||
| Submitter: | Janna Tucker & Associates198 Avenue de la D'emeraldSparks, NV 89434 | ||
| PHONE:FAX: | (775) 342-2612(775) 342-2613 | ||
| Contact Person: | Janna P. Tucker, President, Janna Tucker & Associates | ||
| Date Prepared: | May 26, 1999 | ||
| Trade Name:Common Name:Classification Name: | (Multiple) Nitrile Examination Glove, PowderedNitrile Exam Glove, PowderedNitrile Examination Glove, Class I, 80LZA | ||
| Summary of Safetyand Effectiveness: | Information supporting claims of substantial equivalence, asdefined under the Federal Food, Drug and Cosmetic Act,respecting safety and effectiveness is summarized below. Forthe convenience of the Reviewer, this summary is formatted inaccordance with the Agency's final rule "... (510(k) Summariesand 510(k) Statements..." (21 CFR 807) and can be used toprovide a substantial equivalence summary to anyone requestingit from the preparer. | ||
| NEW DEVICE NAME: | NITRILE EXAMINATION GLOVE,POWDERED | ||
| PREDICATE DEVICE NAME: | Nitrile Exam Glove, Powder-FreeK980677, everything is thesame process except for addingpowder to finished glove. | ||
| Device Description: | The device is powdered Nitrile Exam Gloves. They are non-sterile, single use, disposable gloves. | ||
| Intended Use: | This powdered Nitrile exam glove is intended for medicalpurposes that is worn on the examiner's hand or finger to preventcontamination between patient and examiner. |
EXHIBIT L
Page 28 of 29
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| Indications Statement: | A patient examination glove is a disposable device intended formedical purposes that is worn on the examiner's hand or finger toprevent contamination between patient and examiner. |
|---|---|
| TechnologicalCharacteristics | This Nitrile exam glove has the same technologicalcharacteristics as predicate devices. The device is manufactured instandard sizes. |
| Performance Data: | The device has met and/or exceeded the requirements of thefollowing standards and laboratory tests: |
| ASTM D3578-95Primary Skin Irritation StudyDermal Sensitization StudyFDA Water Leak, before & after aging at AQL 1.5All tests were performed in a certified testing laboratory. | |
| Conclusions: | Based on the 510(k) summaries and 510(k) statements (21 CFR807) and the information provided herein, we conclude that thedevice is substantially equivalent to other like devices under theFederal Food, Drug, and Cosmetic Act. The predicate deviceis the powder-free Nitrile Exam Glove, same manufacturer,(K.980677), except this new glove is powdered. |
JANNA P. TUCKER, President Janna Tucker & Associates Official Correspondent for Ningbo Yujiang Plastic & Rubber Co., Ltd.
EXHIBIT L
Page 29 of 29
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the left.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 1 1999
Ningbo Yujiang Plastic & Rubber Company c/o Ms. Janna P. Tucker Official Correspondent Janna Tucker & Associates 198 De La D'emerald Sparks, Nevada 89434-9550
Re: K991821 Nitrile Examination Glove, Powdered, Blue Trade Name: Requlatory Class: I Product Code: LZA Dated: May 26, 1999 Received: May 27, 1999
Dear Ms. Tucker:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Tucker
this response to your premarket notification Please note: submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Susan Runo
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
APPLICANT:
NINGBO YUJIANG PLASTIC & RUBBER CO., LTD
510(K) NUMBER:
Kg91821
DEVICE NAME:
Blue Nitrile Examination Glove, Powdered
A patient examination glove is a disposable device intended for medical purposes that is A patient examiner's hand or finger to prevent contamination between patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use X
(Optional Format 1-2-96)
EXHIBIT B
Page 2 of 2
Olin S. Lin
(Division Sign-Off)
Bigh-off)
Division of Dental, Infection Control,
eneral Hospital Devices
her
§ 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.