(24 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.
Nitrile Exam Gloves, Powder-Free
The provided document describes the acceptance criteria and the study results for the "Nitrile Exam Gloves, Powder-Free" manufactured by Ningbo Yujiang Plastic & Rubber Co. Ltd. This submission is for a 510(k) premarket notification, which demonstrates substantial equivalence to a legally marketed predicate device, rather than proving efficacy through a controlled clinical trial against specific disease outcomes.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standards/Tests) | Reported Device Performance |
|---|---|
| ASTM D 3578-95 | Met or exceeded |
| ASTM D 5151 | Met or exceeded |
| FDA Water Leak Test (before aging) | Met or exceeded |
| FDA Water Leak Test (after aging) | Met or exceeded |
| Bio-Compatibility | Met or exceeded |
| Dermal Sensitization | Met or exceeded |
| Primary Skin Irritation | Met or exceeded |
| Bio-Burden (bacteria/mold) | Met or exceeded |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual test (ASTM D 3578-95, ASTM D 5151, FDA Water Leak Test, etc.). It only states that the device "met or exceeded" the requirements of these standards. The data provenance is not explicitly mentioned with respect to country of origin, but it is implied to be from testing conducted by or for Ningbo Yujiang Plastic & Rubber Co. Ltd. to meet US FDA requirements. The tests are general laboratory analyses, not human clinical trials, so the terms "retrospective" or "prospective" are not applicable in the typical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. For this type of device (nitrile exam gloves), "ground truth" is established by adherence to established engineering and material performance standards (e.g., ASTM standards) and biocompatibility tests, not by expert consensus on clinical images or patient outcomes. The "experts" involved would be relevant laboratory technicians and engineers performing and interpreting the results of these standardized tests. Their qualifications are implicitly that they are certified or trained to perform such tests according to the specified standards.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements against defined pass/fail criteria within established standards. There is no need for human adjudication in the sense of resolving conflicting interpretations of complex data like in a clinical trial.
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 device is not an AI-powered diagnostic tool, but rather a medical glove. Therefore, an MRMC study and the concept of AI assistance for human readers are irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or software. It is a physical medical device (gloves).
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on established industry standards and regulatory tests. These include:
- ASTM D 3578-95: Standard Specification for Rubber Examination Gloves
- ASTM D 5151: Standard Test Method for Detection of Holes in Medical Gloves
- FDA Water Leak Test: A regulatory requirement for medical gloves.
- Bio-Compatibility Tests: (e.g., Dermal Sensitization, Primary Skin Irritation) to assess biological safety.
- Bio-Burden (bacteria/mold) Test: To assess the microbial load.
These standards define the acceptable physical properties, barrier integrity, and biological safety of the gloves.
8. The Sample Size for the Training Set
Not applicable. As this is not an AI/ML device, there is no "training set." The device performance is assessed directly against predefined standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of medical device.
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Image /page/0/Picture/0 description: The image shows the logo for Janna Tucker & Associates. The logo features a stylized figure of Kokopelli, a fertility deity, playing a flute. The text "JANNA TUCKER & ASSOCIATES" is written in bold, uppercase letters to the right of the figure.
MAR 1 6 1998
19001 S. Richfield #185 Green Valley, AZ 85614 Telephone: (520) 625-2904 Fax: (520) 625-3908
510(k) SUMMARY
| Submitted By: | |
|---|---|
Janna Tucker & Associates 19001 S. Richfield #185 Green Valley, AZ 85614 520-625-2904 Phone: FAX: 520-625-3908
- Janna P. Tucker, Official Correspondent for Contact Person: Ningbo Yujiang Plastic & Rubber Co. Ltd.
17 February 1998 Date of Submission:
Nitrile Exam Gloves, Powder-Free Device Name:
(Multiple Labels) Nitrile Exam Glove, Powder Free Proprietary Name:
- This device will be marketed to healthcare professionals at dentist, Labels/Labeling: and doctor offices, laboratories, clinics and hospitals through its intended use.
- A patient examination glove is a disposable device intended for Intended Use: medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Substantial Equivalence:
This device is equivalent to those in commercial distribution. They are to be worn as a protective device on the examiner's hand or finger.
Both in its intended use and/or physical characteristics, this device is equivalent to devices currently marketed by U.S. companies. It is substantially equivalent to the device manufactured by Intlux Pacific SDN. BHD. K970216 for a Nitrile Exam Glove, Powdered,
EXHIBIT L
Page 31 of 32
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Test Results (Means and/or Results):
This device has met or exceeded the following standards/tests:
ASTM D 3578-95 ASTM D 5151 FDA Water Leak Test (before & after aging) Bio-Compatibility Dermal Sensitization
Primary Skin Irritation Bio-Burden (bacteria/mold)
Conclusions:
This device is substantially equivalent to the Influx Pacific SDN. BHD. device approved under K970216.
EXHIBIT L
Page 32 of 32
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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 features a stylized depiction of an eagle or bird in flight, composed of three curved lines that suggest the wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 6 1998 Ningbo Yujiang Plastic & Rubber Company, Ltd. C/O Janna Tucker & Associates 19001 S. Richfield #185 85614 Green Valley, Arizona
K980677 Re : Nitrile Examination Glove, Powder Free Trade Name: Requlatory Class: I Product Code: LZA February 17, 1998 Dated: Received: February 20, 1998
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 The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. . ਉੱ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice_requirement , as set ...... forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Ms. Tucker
through 542 of the Act for devices under the Electronic Chrough 542 Of the ace as rought ons, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA deborny of substantial equivalence of your device to a legally rinding of bubbeandian oquresults in a classification for your marketed predicate actro 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 diagnostic devices), 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 che regulation Chercred, "Mirranan") 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,
Patrici Cucenati/for
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: | |
| DEVICE NAME: | Nitrile Exam Glove, Powder-Free |
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | K980677 |
Prescription Use_ (Per 21 CFR 801.109)
. "
OR
Over-The-Counter Use X
(Optional Format 1-2-96)
EXHIBIT B
Page 2 of 32
§ 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.