(115 days)
The N-DEX® NightHawk® Black Nitrile Powder-Free Medical Examination Glove is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner (21 CFR 880.6250).
The N-DEX® NightHawk® Black Nitrile Powder-Free Medical Examination Glove is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner.
Here's an analysis of the provided 510(k) submission, focusing on the acceptance criteria and the study that proves the device meets those criteria:
Device: N-DEX® NightHawk® Black Nitrile Powder-Free Medical Examination Glove (Non-Sterile)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard/Test) | Predicate Device Performance | Proposed Device Performance | Type of Test |
|---|---|---|---|
| ASTM D 6319-00a (Performance) | Conforms | Conforms | Non-Clinical |
| ASTM D 6124-01 (Performance) | Conforms | N/A (Updated to 6124-06) | Non-Clinical |
| ASTM D 6124-06 (Performance) | N/A (Older standard) | Conforms | Non-Clinical |
| ASTM D 5151-99 (Water Tightness) | Conforms | N/A (Updated to 5151-06) | Non-Clinical |
| ASTM D 5151-06 (Water Tightness) | N/A (Older standard) | Conforms | Non-Clinical |
| ISO 10993-10 (Skin Irritation) | Passes | Passes | Biocompatibility |
| ISO 10993-10 (Sensitization) | Passes | Passes | Biocompatibility |
| ISO 10993-5 (Cytotoxicity) | Not tested | Passes | Biocompatibility |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the non-clinical performance tests (ASTM standards) or the biocompatibility tests (ISO standards). The results are reported as "Conforms," "Passes," or "Not tested," implying that the testing was conducted according to the methodology outlined in the respective standards.
For biocompatibility, the tests were conducted, but the specific number of animals or human subjects (if applicable for irritation/sensitization under specific protocols) is not provided.
The data provenance is from testing conducted by the manufacturer, Best Glove, Inc. No country of origin for the data is specified beyond the company's location in the USA. The tests are prospective as they were conducted to demonstrate the safety and effectiveness of the new device for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This submission does not involve an expert-reviewed test set in the way a medical image analysis or diagnostic device might. The "ground truth" for this device (medical examination glove) is established by its adherence to established performance standards (ASTM) and biocompatibility standards (ISO).
Therefore, there were no "experts" in the traditional sense involved in establishing a ground truth for a test set for diagnostic accuracy. Instead, the "ground truth" is defined by the passing criteria of the specified international standards for glove performance and safety. The expertise lies in the certified laboratories and personnel who conduct these standardized tests according to the established protocols.
4. Adjudication Method for the Test Set
Not applicable. This device is not a diagnostic tool requiring expert adjudication of results. The performance and biocompatibility tests are based on objective measurements and established pass/fail criteria within the relevant ASTM and ISO standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret data (e.g., medical images) and AI might assist in that interpretation. This submission is for a medical examination glove, which does not involve human readers interpreting diagnostic information.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical medical glove and does not involve an algorithm or AI.
7. The Type of Ground Truth Used
The ground truth used is based on established objective performance criteria and biocompatibility thresholds defined by recognized international standards:
- Performance: ASTM D 6319-00a/06, ASTM D 6124-01/06, ASTM D 5151-99/06. These standards define physical properties like tensile strength, elongation, puncture resistance, and watertightness, with specific acceptance limits.
- Biocompatibility: ISO 10993-10 (for irritation and sensitization) and ISO 10993-5 (for cytotoxicity). These standards define acceptable biological responses when the device comes into contact with tissues.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical glove and does not involve a "training set" in the context of machine learning or AI algorithms. The manufacturing process and quality control are based on established engineering principles and quality management systems, not data training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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K0+2/25
510(k) Submission For Black Nitrile Powder-Free Medical Exam Glove
Summary Of Safety And Effectiveness
A. Information
l.
| Submitter's | ||
|---|---|---|
| Name: | Best Glove, Inc. | NOV 21 2008 |
| Address: | 579 Edison StreetMenlo, GA 30731-6335 | |
| Telephone Number: | 706-862-6712 | |
| Contact person: | Neil Dow | |
| Name of Device | ||
| Trade or Proprietary name: | Nitrile Powder-Free Medical ExaminationGlove (Black). | |
| Common or Usual name: | Non-sterile Powder-Free Patient Examinationglove. | |
| Classification Name: | Patient Examination Glove (80LZA, 21 CFR880.6250) |
-
- Predicate Device: Nitrile Powder-Free medical Examination Glove (green)
Submission Number: K012899
- Predicate Device: Nitrile Powder-Free medical Examination Glove (green)
-
- Description Of Device
The N-DEX® NightHawk® Black Nitrile Powder-Free Medical Examination Glove is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner.
- Description Of Device
-
- Statement of intended use, including descriptions of the disease or conditions that the device will address:
This is a disposable device intended for medical purposes that is worn on the examiners hands to prevent contamination between the patient and the examiner. Powder-Free examination gloves are suitable in situations where powder is not desirable.
- Statement of intended use, including descriptions of the disease or conditions that the device will address:
-
- Explanation of similarities or differences to predicate device
The proposed device is identical to the predicate device except for the following:
- Explanation of similarities or differences to predicate device
The proposed device has been rendered black instead of green.
B. If SE decision is based on performance:
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1. Non-Clinical Tests
| Specification | Predicate Device | Proposed Device |
|---|---|---|
| Nitrile Powder-FreeMedical ExaminationGlove (green) | Nitrile Powder-FreeMedical ExaminationGlove (black) | |
| Performance standards (conforms) | ASTM D 6319-00aASTM D 6124-01 | ASTM D 6319-00aASTM D 6124-06 |
| Water tightness (conforms) | ASTM D 5151-99 | ASTM D 5151-06 |
2. Clinical Tests (Animal Studies)
| Biocompatibility | Predicate Device | Proposed Device |
|---|---|---|
| ISO Skin Irritation Study (ISO 10993-10) | Passes | Passes |
| ISO Closed Patch Sensitization Study (ISO 10993-10) | Passes | Passes |
| Cytotoxicity Study (ISO 10993-5) | Not tested | Passes |
REPORTS OF SAFETY OR EFFECTIVENSS DATA OBTAINED (With specific reference to adverse effects and complications)
See Section J: Biocompatibility Testing.
CONCLUSIONS DRAWN FROM NON CLINICAL AND CLINICAL TESTS THAT DEMONSTRATE SAFETY AND EFFECTIVENESS, AND PERFORMANCE EQUAL TO OR BETTER THAN THE PREDICATE PRODUCT
The Nitrile Powder-Free Medical Examination Glove (black) has been carefully compared to a legally marketed device in the 510(k). The data summaries indicate that the proposed product meets or exceeds accepted scores for the predicate product in both physical and nonclinical tests and satisfies the requirements for a safe and effective powderfree medical glove.
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Pursuant to 21 C.F.R. 807.87 (k), I, Neil Dow, Regulatory Affairs and Quality Assurance Manager, certify that to the best of my knowledge and belief, and based upon the data and information submitted to me in the course of my responsibilities as Regulatory Affairs and Quality Assurance Manager for Best Glove, Inc, and in reliance thereupon, the data and information submitted in this premarket notification are truthful and accurate and that no facts material to a review of the substantial equivalence of this device have been knowingly omitted from this submission.
Hii Dow
Neil Dow
Regulatory Affuirs and Quality Assurance Manager
24 Sep 2008
Date
Section K
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Image /page/3/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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Neil Dow Regulatory Affairs & Quality Assurance Manager Best Glove, Incorporated 579 Edison Street Menlo, Georgia 30731-6335 United States
NOV 2 1 2008
Re: K082125
Trade/Device Name: N-DEX® NightHawk® Black Nitrile Powder-Free Medical Examination Glove, Non-Sterile Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: I.Z.A Dated: September 30, 2008 Received: October 20, 2008
Dear Mr. Dow:
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 cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your 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 - Mr. Dow
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 rcquirements as set forth in the quality systems (QS) 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 linding 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 Conter for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Clas
Chiu S. Lin, Ph. D Division 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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Indication for Use
510(k) Number (if known):
Device Name: N-DEX® NightHawk® Black Nitrile Powder-Free Medical Examination Glove, Non-Sterile
Indications For Use:
The N-DEX® NightHawk® Black Nitrile Powder-Free Medical Examination Glove is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner (21 CFR 880.6250).
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use x (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Of device Evaluation (ODE)
Shiela A Murphy, D
Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices
510(k) Number:
Section D
Page 1 of 1
§ 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.