(70 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, White
The provided text describes a 510(k) submission for "Nitrile Exam Gloves, Powder-Free, White." The submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance criteria through a clinical trial or algorithm-based assessment. Therefore, many of the requested categories for AI/algorithm-driven device studies are not applicable.
Here's an analysis based on the provided text, with explanations for non-applicable criteria:
Acceptance Criteria and Device Performance for Nitrile Exam Gloves, Powder-Free, White
This submission pertains to a medical glove, a Class I device, and therefore the "acceptance criteria" are related to established physical and biocompatibility standards for such devices, rather than performance metrics for an AI algorithm. The "study" refers to a series of tests against these standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard Met (Type of Test) | Reported Device Performance (Means and/or Results) |
|---|---|
| ASTM D 3578-95 (Standard Specification for Rubber Examination Gloves) | Met or exceeded |
| ASTM D 5151 (Standard Test Method for Detection of Holes in Medical Gloves) | Met or exceeded |
| FDA Water Leak Test (before & after aging) | Met or exceeded |
| Bio-Compatibility (e.g., cytotoxicity, sensitization) | 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 the data provenance
- Sample Size: Not explicitly stated in the provided text for each test. General reference to "Test Results (Means and/or Results)" suggests samples were tested according to standard protocols for each criterion.
- Data Provenance: Not specified, but implied to be from laboratory testing of the manufactured gloves. The country of origin of the data is not mentioned. It is prospective testing of the device for submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical medical device, not an AI or diagnostic imaging device requiring expert ground truth for a test set. The "ground truth" is defined by the established ASTM and FDA standards for glove performance.
4. Adjudication method for the test set
- Not Applicable. As per point 3, there's no diagnostic decision or interpretation requiring adjudication. Performance is measured objectively against predefined thresholds in the standards.
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-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm.
7. The type of ground truth used
- Objective Standards: The "ground truth" is defined by the established, published standards and test methods from ASTM and the FDA (e.g., ASTM D 3578-95, ASTM D 5151, FDA Water Leak Test, Bio-Compatibility tests assessing specific biological reactions). These standards set the minimum acceptable performance metrics for the glove.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML algorithm that requires a training set. The manufacturing process of the gloves is designed to meet the standards, not "trained" on data.
9. How the ground truth for the training set was established
- Not Applicable. As per point 8.
Summary Notes:
The provided document is a 510(k) summary for a relatively low-risk medical device (Class I), focusing on demonstrating substantial equivalence to a legally marketed predicate device. The "proof" that the device meets acceptance criteria comes from laboratory testing against established governmental and industry standards for its physical and biocompatibility properties. The framework for AI/ML device evaluation does not directly apply here.
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Image /page/0/Picture/0 description: The image shows the logo for Janna Tucker & Associates. The logo features a stylized Kokopelli figure on the left. The text "JANNA TUCKER & ASSOCIATES" is written in a bold, sans-serif font to the right of the figure.
FEB 2 5 1998
510(k) SUMMARY
19001 S. Richfield #185 Green Valley, AZ 85614 Telephone: (520) 625-2904 Fax: (520) 625-13908
Submitted Bv:
Janna Tucker & Associates 19001 S. Richfield #185 Green Valley, AZ 85614 520-625-2904 Phone: FAX: 520-625-3908
Contact Person: Janna P. Tucker, Official Correspondent for Sinochem Ningbo Latex Glove Factory
Date of Submission: 16 December 1997
Device Name: Nitrile Exam Gloves, Powder-Free, White
Proprietary Name: (Multiple Labels) Nitrile Exam Glove, Powder Free
Labels/Labeling: This device will be marketed to healthcare professionals at dentist. 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 Influx Pacific SDN. BHD. K970216 for a Nitrile Exam Glove, Powdered,
EXHIBIT M
Page 33 of 34
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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 M
Page 34 of 34
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EEB 2 5 1998
Ms. Janna P. Tucker Official Correspondent Sinochem Ningbo Latex Gloves Factory C/O Janna Tucker Associates 19001 S. Richfield #185 Green Valley, Arizona 85614
K974710 Re : Nitrile Exam Glove, Powder-Free/White Trade Name: Regulatory Class: I Product Code: LZA Dated: January 19, 1998 Received: January 26, 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 Existing major be subject to such additional controls. regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಡಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (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 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 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 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,
Patricia Crassitoffer
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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INDICATIONS FOR USE
| APPLICANT: | Sinochem Ningbo Latex Glove Factory |
|---|---|
| 510(K) NUMBER: | K974710 |
| 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)
Chùm S. Lim
(Division Sign-Off)
Division of Dental, Infection Control,
510(k) Nu
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
EXHIBIT B
Page 2 of 34.
§ 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.