(47 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.
POWDER-FREE NITRILE EXAM GLOVES, COLOR: BLUE
The provided text describes the 510(k) summary for the NINGBO TIANSHUN RUBBER PRODUCTS CO., LTD. Powder-Free Nitrile Exam Gloves, Color: Blue. This is a Class I medical device, specifically patient examination gloves.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard/Test) | Reported Device Performance |
|---|---|
| ASTM D 6124-01 | Met or exceeded |
| ASTM D 6319-00aE3 | Met or exceeded |
| ASTM D 5151-99 | Met or exceeded |
| ISO 2859 | Met or exceeded |
| MIL Std 105E | Met or exceeded |
| Bio-Compatibility: Dermal Sensitization | Met or exceeded |
| Bio-Compatibility: Primary Skin Irritation | Met or exceeded |
| Bio-Burden (Procedure Method 8315) | Met or exceeded |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for testing each standard. It only mentions that the device "met or exceeded" the listed standards. For devices like examination gloves, testing typically involves destructive sampling from production batches. The provenance of this data is not specified in terms of country of origin or whether it was retrospective or prospective, though it would generally be prospective testing conducted by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable to the evaluation of examination gloves. The "ground truth" for glove performance is established by the specifications defined in the referenced industry standards (e.g., ASTM, ISO), which involve objective physical, chemical, and biological measurements, not expert consensus on interpretations.
4. Adjudication method for the test set:
Not applicable. The tests are objective measurements against defined pass/fail criteria within the 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 for a physical medical device (examination gloves), not an AI-powered diagnostic tool engaging human "readers."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is for a physical medical device (examination gloves), not an algorithm.
7. The type of ground truth used:
The ground truth is established by the specifications and testing methodologies outlined in the referenced industry standards (ASTM D 6124-01, ASTM D 6319-00aE3, ASTM D 5151-99, ISO 2859, MIL Std 105E) and specific biocompatibility and bioburden testing procedures (e.g., Procedure Method 8315). These standards define acceptable limits for properties like dimensions, physical integrity (e.g., tensile strength, elongation), barrier protection (e.g., pinholes), and biological safety.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device that requires a "training set."
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/machine learning device. The "ground truth" for manufacturing and quality control of the gloves is based on adherence to the aforementioned industry standards.
Summary of Study (from the provided text):
The study demonstrating the device meets the acceptance criteria is implicitly the testing performed against a series of established national and international standards for patient examination gloves. The submission states, "This device has met or exceeded the following standards and/or tests." This implies that the manufacturer conducted the required tests as per these standards, and the results demonstrated compliance. The specific details of these tests (e.g., number of gloves tested for tensile strength, specific bioburden levels) are not provided in this summary but would be part of the full 510(k) submission.
The conclusion of the summary is that the device is "substantially equivalent to the devices approved as K011286 and K000670," which suggests that its performance against these standards is comparable to previously cleared predicate devices.
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Ko23762
| 510(k) SUMMARY | |
|---|---|
| Submitted For: | NINGBO TIANSHUN RUBBER PRODUCTSCO., LTD. |
| Submitted By: | TUCKER & ASSOCIATESOfficial Correspondent for NINGBO TIANSHUN ETC.JANNA P. TUCKER, President-CEO198 Avenue de la D'emeraldSparks, NV 89434-9550Phone:775-342-2612Fax:775-342-2613E-Mail:Tuckerjan@aol.com |
| Date of Submission: | 30 October 2002 |
| Device Name: | POWDER-FREE NITRILE EXAM GLOVES,COLOR: BLUEClass I Device, 80LZA |
| Proprietary Name: | (Multiple Private Labels) |
| Labels/Labeling: | This device will be marketed to healthcare professionals atDentist and Doctor Offices, Laboratories, Clinics andHospitals through its distributors for the intended use. |
| Intended Use: | A patient examination glove is a disposable device intendedfor medical purposes that is worn on the examiner's handor finger to prevent contamination between patient andexaminer. |
| Substantial Equivalence: | Both in its intended use and/or physicalcharacteristics, this device is equivalent to devicescurrently marketed by U.S. companies. It is SubstantiallyEquivalent to the gloves manufactured by Ningbo YujiangPlastic & Rubber Co., Ltd. (K011286) and Shasta AsiaPartners Gloves Mfg Co., Ltd. (K000670). |
EXHIBIT N
Page 44 of 45
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510k) Summary page 2.
Test Results (Means and/or Successful Results:
This device has met or exceeded the following standards and/or tests:
ASTM D 6124-01 ASTM D 6319-00aE3 ASTM D 5151-99 ISO 2859 MIL Std 105E Bio-Compatibility: Dermal Sensitization Primary Skin Irritation Bio-Burden (Procedure Method 8315)
Conclusion:
This device is substantially equivalent to the devices approved as K011286 and K000670.
EXHIBIT N
Page 45 of 45
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 8 200
Ningbo Tianshun Rubber Products Company Limi C/O Ms. Janna P. Tucker Tucker & Associates 198 Avenue De La D' emerald Sparks, Nevada 89434-9550
Re: K023702
Trade/Device Name: Powder-Free Nitrile Examination Gloves, Color: Blud Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: October 30, 2002 Received: November 1, 2002
Dear Ms. Tucker:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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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Page 2 - Ms. Tucker
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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). 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Susan Runner
Timothy A. Ulatowski 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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INDICATIONS FOR US
APPLICANT:
NINGBO TIANSHUN RUBBER PRODUCTS CO., LTD
510(k) NUMBER:
DEVICE NAME:
POWDER FREE NITRILE EXAM GLOVES, COLOR: BLUE
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)
Prescription Use (Per 21 CFR 801.109)
EXHIBIT B
Page 2 of 45
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devices
510(k) Number. K023702
§ 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.