(23 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, Blue
This document is a 510(k) summary for a Nitrile Exam Glove, Powder-Free, Blue. It is a medical device submission, and the content provided does not relate to an AI/ML powered device or a study demonstrating its performance. Therefore, I cannot fulfill your request for detailed information about acceptance criteria, study design, and AI-specific metrics like MRMC studies or human reader improvement, as these concepts are not applicable to the provided document.
The document discusses the substantial equivalence of the Nitrile Exam Glove to already marketed devices based on physical characteristics and intended use. The "Test Results" section (K980802 on page 34 of 34) lists the standards and tests that the device has met or exceeded, which serve as the acceptance criteria for the glove's performance.
Here's a breakdown of the information that can be extracted relevant to your request, adapted for a non-AI medical device submission:
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria (Standards/Tests Met) | Reported Device Performance |
|---|---|
| ASTM D 3578-95 | Met or exceeded |
| ASTM D 5151 | Met or exceeded |
| FDA Water Leak Test (before & after aging) | Met or exceeded |
| Nitrile Glove Draft ASTM, Sept 97 | Met or exceeded |
| Bio-Compatibility 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: The document does not specify the exact sample sizes used for each test. For medical devices like gloves, testing is typically done on representative batches according to the specified ASTM standards.
- Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted on the manufacturer's product (Sinochem Ningbo Latex Gloves Factory). The document does not specify country of origin for the data itself, but the device is manufactured by Sinochem Ningbo Latex Gloves Factory, implying the testing was done on their product. It is a retrospective evaluation of the product's compliance with established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not directly applicable to the testing of examination gloves. The "ground truth" here is adherence to objective, standardized test methodology and performance thresholds defined by organizations like ASTM and the FDA. The experts involved would be the certified laboratory technicians and engineers performing these specific tests, adhering to the standard protocols. Their qualifications would be in laboratory practices and materials testing, not medical diagnosis or interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Performance testing for medical gloves involves objective measurements against predefined standards, not subjective interpretations requiring adjudication.
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/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used:
- The "ground truth" is defined by the objective performance criteria specified in the referenced ASTM standards and FDA guidelines (e.g., specific tensile strength, elongation, water leak rate, biocompatibility thresholds).
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device. There is no concept of a "training set" in the context of standard physical and biocompatibility testing for medical gloves.
9. How the ground truth for the training set was established:
- Not applicable.
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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 a Kokopelli, a fertility deity often depicted as a humpbacked flute player. The text "JANNA TUCKER & ASSOCIATES" is written in bold, sans-serif font to the right of the Kokopelli figure.
MAR 2 5 1998
19001 S. Richfield #185 Green Valley, AZ 85614 Telephone: (520) 625-2904 Fax: (520) 625-3908
510(k) SUMMAR Y
| Submitted By: | Janna Tucker & Associates19001 S. Richfield #185Green Valley, AZ 85614Phone: 520-625-2904FAX: 520-625-3908 |
|---|---|
| Contact Person: | Janna P. Tucker, Official Correspondent forSinochem Ningbo Latex Gloves Factory |
| Date of Submission: | 27 February 1998 |
| Device Name: | Nitrile Exam Gloves, Powder-Free, Blue |
| Proprietary Name: | (Multiple Labels) Nitrile Exam Glove, Powder Free, Blue |
| Labels/Labeling: | This device will be marketed to healthcare professionals at dentistand doctor offices, laboratories, clinics and hospitals through itsintended use. |
| Intended Use: | A patient examination glove is a disposable device intended formedical purposes that is worn on the examiner's hand or fingerto 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 Sinochem Ningbo Latex Gloves Factory for a Nitrile Exam Glove, Powder-Free, White K974710.
EXHIBIT M
Page 33 of 34
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Test Results (Means This device has met or exceeded the following and/or Results): standards/tests: ASTM D 3578-95 ASTM D 5151FDA Water Leak Test (before & after aging) Nitrile Glove Draft ASTM, Sept 97. Bio-Compatibility Dermal Sensitization Primary Skin Irritation Bio-Burden (bacteria/mold) This device is substantially equivalent to the Sinochem Ningbo Conclusions: Latex Gloves Factory device approved under K974710.
EXHIBIT M
Page 34 of 34
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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 stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 25 1998
Sinochem Ningbo Latex Glove Factory C/O Ms. Janna P. Tucker Official Correspondent for Sinochem Ningbo Latex Glove Factory Janna Tucker & Associates 19001 South Richfield #185 Green Valley, Arizona 85614
Re : K980802 Nitrile Exam Glove, Powder-Free, Blue Trade Name: Requlatory Class: I Product Code: LZA Dated: February 27, 1998 Received: March 2, 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 of the Act. The general controls provisions of the Act include reguirements 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ 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 regulation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of
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Page 2 - Ms. Tucker
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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 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,
Whittier
Timothy A. 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
Sinochem Ningbo Latex Gloves Factory
510(K) NUMBER:
K9Y80802
DEVICE NAME:
Nitrile Exam Glove, Powder-Free, Blue
A patient examination glove is a disposable device intended for medical purposes that is I I parvate causiner'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 K980802
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.