(115 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a medical examination glove, with no mention of AI or ML.
No
The device prevents contamination but is not described as treating or curing any medical condition.
No
The device is a medical examination glove, used to prevent contamination, not to diagnose a condition.
No
The device is a physical medical examination glove, not a software application. The description clearly states it is a "disposable device intended for medical purposes; that is worn on the examiner's hand".
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Intended Use: The intended use of the N-DEX® NightHawk® Black Nitrile Powder-Free Medical Examination Glove is to be worn on the examiner's hand to prevent contamination between the patient and examiner. This is a physical barrier device, not a test performed on a sample.
- Device Description: The description reinforces that it's a disposable device worn on the hand for contamination prevention.
- Lack of IVD characteristics: The document does not mention any analysis of biological samples, diagnostic testing, or any of the typical components or processes associated with IVDs.
The device is clearly described as a medical examination glove, which falls under a different regulatory classification than IVDs.
N/A
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests:
Performance standards (conforms): ASTM D 6319-00a, ASTM D 6124-06
Water tightness (conforms): ASTM D 5151-06
Clinical Tests (Animal Studies):
Biocompatibility:
ISO Skin Irritation Study (ISO 10993-10): Passes
ISO Closed Patch Sensitization Study (ISO 10993-10): Passes
Cytotoxicity Study (ISO 10993-5): Passes
Conclusions: The Nitrile Powder-Free Medical Examination Glove (black) 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 Street | |
| Menlo, GA 30731-6335 | ||
| Telephone Number: | 706-862-6712 | |
| Contact person: | Neil Dow | |
| Name of Device | ||
| Trade or Proprietary name: | Nitrile Powder-Free Medical Examination | |
| Glove (Black). | ||
| Common or Usual name: | Non-sterile Powder-Free Patient Examination | |
| glove. | ||
| Classification Name: | Patient Examination Glove (80LZA, 21 CFR | |
| 880.6250) |
-
- 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:
1
1. Non-Clinical Tests
| Specification | Predicate Device | Proposed Device |
|---|---|---|
| Nitrile Powder-Free | ||
| Medical Examination | ||
| Glove (green) | Nitrile Powder-Free | |
| Medical Examination | ||
| Glove (black) | ||
| Performance standards (conforms) | ASTM D 6319-00a | |
| ASTM D 6124-01 | ASTM D 6319-00a | |
| ASTM 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.
2
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
3
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.
4
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
5
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
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