(172 days)
The N-DEX® BWC™ Pink 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)
This device has been tested for use with specific chemotherapy drugs. This device is not intended to be used as a chemical barrier.
The N-DEX® BWC™ 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.
This 510(k) submission describes the N-DEX® BWC™ Nitrile Powder-Free Medical Examination Glove (pink) and its substantial equivalence to a predicate device.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a medical examination glove, and its performance is evaluated against established ASTM standards and biocompatibility tests.
| Acceptance Criteria (Standards/Tests) | Predicate Device Performance | Proposed Device Performance |
|---|---|---|
| Performance Standards (Physical Properties) | ||
| ASTM D 6319-00a (Nitrile Examination Gloves) | Conforms | Conforms (ASTM D 6319-00a3 listed, likely a minor revision) |
| ASTM D 6124-01 (Powder Residue on Medical Gloves) | Conforms | Conforms (ASTM D 6124-06 listed, likely a minor revision) |
| ASTM D 5151-99 (Water penetration through finished surgical gloves) | Conforms | Conforms (ASTM D 5151-06 listed, likely a minor revision) |
| Biocompatibility | ||
| 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 (for predicate, but accepted for proposed as part of equivalence) | Passes |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the sample sizes used for each ASTM standard test or biocompatibility study. However, these standards typically specify minimum sample sizes for testing to achieve statistically significant results.
- Data Provenance: The studies were conducted by Best Glove, Inc. and are considered retrospective in the sense that the data is presented to demonstrate conformance to existing standards rather than generated from a new clinical trial. The country of origin for the data is not explicitly stated, but given the company's US address and compliance with ASTM and ISO standards, it is highly likely the testing was performed in the US or in accredited labs adhering to international standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of submission for a medical glove does not involve establishing ground truth from human expert consensus in the way an AI diagnostic device would. Instead, ground truth for material properties is established by adherence to validated ASTM and ISO test methods performed in laboratories. The "experts" involved would be qualified laboratory technicians, engineers, and scientists specialized in materials testing and biocompatibility. Their qualifications would be based on their expertise in performing and interpreting these specific tests according to regulatory and industry standards.
4. Adjudication Method for the Test Set
Not applicable in the context of this device. The conformance to standards is determined by objective laboratory measurements and interpretations of those results against the criteria defined by the respective ASTM and ISO standards. There is no ambiguous result that requires human adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data. For a medical examination glove, the "effectiveness" is primarily determined by its physical properties and biocompatibility, as measured by standard laboratory tests, not by human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance evaluation in this submission is effectively a "standalone" evaluation of the glove's physical and biological properties. The tests (ASTM for physical properties, ISO for biocompatibility) are objective measurements of the device itself, without any human-in-the-loop diagnostic or interpretive component.
7. The Type of Ground Truth Used
The ground truth used is based on:
- Standardized Test Methods and Specifications: Conformance to specific ASTM and ISO standards (e.g., ASTM D 6319-00a for glove properties, ISO 10993 for biocompatibility). These standards define objective, measurable criteria for acceptable performance.
- Predicate Device Performance: The primary ground truth for demonstrating substantial equivalence is the performance of the legally marketed predicate device (Ultimate N-DEX® Nitrile Powder-Free Medical Examination Glove, Non-Sterile (blue), K001375). The proposed device must meet or exceed the performance of the predicate device for relevant parameters.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" in the context of manufacturing would relate to process control and quality assurance to ensure consistent product attributes, not a data-driven training of a model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, there is no AI/ML training set for this device.
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510(k) Submission For Pink Nitrile Powder-Free Medical Exam Glove
Summary Of Safety And Effectiveness
A. Information
-
- Submitter's
Name: Address:
- Submitter's
Address:
Best Glove, Inc. 579 Edison Street Menlo, GA 30731-6335 706-862-6712 Neil Dow
FEB 1 0 2009
Telephone Number: Contact person:
- Name of Device
Trade or Proprietary name:
Common or Usual name:
Classification Name:
- Predicate Device:
N-DEX® BWC™ Nitrile Powder-Free Medical Examination Glove, Non-Sterile
Non-sterile Powder-Free Patient Examination glove.
Patient Examination Glove (80LZC, 21 CFR 880.6250)
Ultimate N-DEX® Nitrile Powder-Free Medical Examination Glove, Non-Sterile (blue)
Submission Number: K001375
4. Description of Device
The N-DEX® BWC™ 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.
- Statement of intended use, including descriptions of the disease or conditions that 5. 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. This device is used for protection against exposure to indicated chemotherapy drugs.
Section K
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Explanation of similarities or differences to predicate device 6.
The proposed device is identical to the predicate device except for the following:
- ◆ The proposed device has been rendered pink instead of blue.
- The proposed device is shorter in overall length (9½" vs. 11" for the predicate device).
- The proposed device is thinner (4-mil vs. 6-mil for the predicate device) ◆
B. If SE decision is based on performance:
-
- Non-Clinical Tests
| Specification | Predicate Device | Proposed Device |
|---|---|---|
| Nitrile Powder-FreeMedical ExaminationGlove, Non-Sterile(blue) | Nitrile Powder-FreeMedical ExaminationGlove, Non-Sterile(pink) | |
| Performance standards (conforms) | ASTM D 6319-00aASTM D 6124-01 | ASTM D 6319-00a3ASTM 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 |
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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 pink Nitrile Powder-Free Medical Examination Glove 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.
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.
Neil Dow
Regulatory Affairs and
Quality Assurance Manager
7 Jan. 2009
Date
Section K
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 0 2009
Best Glove, Incorporated Mr. Neil Dow RA/QA Manager 579 Edison Street Menlo, Georgia 30731-6335
Re: K082428
Trade/Device Name: N-DEX® BWC™ Nitrile Powder-Free Medical Examination Glove, Non-Sterile Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZC Dated: January 8, 2009 Received: January 13, 2009
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 either 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.
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
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Page 2 - Mr. Dow
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements 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 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 Center 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.
Anthony D. nutzman
Ginette Y. Michaud. M.D. Acting 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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510(k) Submission For Pink Nitrile Powder-Free Medical Exam Glove
Indication for Use
510(k) Number (if known):
Device Name: N-DEX® Pink Nitrile Powder-Free Medical Examination Glove Indications For Use:
The N-DEX® BWC™ Pink 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)
This device has been tested for use with specific chemotherapy drugs. This device is not intended to be used as a chemical barrier.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Shuley M. Murphy
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Section D
510(k) Number: K082428
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.