(21 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of a medical glove, with no mention of AI or ML technology.
No
Explanation: A medical examination glove is intended to prevent contamination and act as a barrier, not to treat or cure a disease or condition.
No
This device is a medical examination glove, which is a barrier device used to prevent contamination. It does not perform any diagnostic function.
No
The device is a physical glove made of nitrile rubber, not software. The description focuses on material properties and physical performance tests.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "worn on the examiner's hand, to prevent contamination between the patient and examiner." This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description focuses on the physical properties of the glove as a barrier to fluids and pathogens. It does not mention any components or processes related to analyzing samples or providing diagnostic information.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic results, which are hallmarks of IVD devices.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This glove's purpose is to prevent the transfer of contaminants, which is a protective function, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Nitrile Powder-Free Medical Examination Glove (brown) 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
- How the device functions: Nitrile rubber films form an excellent barrier to body fluids and bloodborne pathogens.
- Scientific concepts that form the basis for the device: The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing fine movement necessary for treatment. The absence of natural rubber latex in the product yields no latex protein allergens.
- Physical and performance characteristics such as design, materials, and physical properties: Nitrile rubber is known to create a superior barrier to bloodborne pathogens and body fluids.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner / Medical purposes
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: ASTM for both Proposed and Predicate devices. Watertightness: ASTM for both Proposed and Predicate devices.
Clinical Tests:
Specification Safety: Rabbit Irritation - Passes for both Proposed and Predicate. Guinea Pig Sensitization - Passes for both Proposed and Predicate. Modified Draze Test (Human Study) - N/A for Proposed, Passes for predicate K992170.
Conclusion: The Nitrile Powder-Free Medical Examination Glove (brown) meets or exceeds accepted scores for the predicate product in both physical and nonclinical tests and satisfies the requirements for a safe and effective "powder-free" 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
AUG - 1 2001
510(K) SUBMISSION FOR BROWN NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 2001-06-29
SUMMARY OF SAFETY AND EFFECTIVENESS
A. INFORMATION
- SUBMITTER'S Name:
Address:
BEST MANUFACTURING COMPANY
579 Edison Street Menlo, GA 30731 USA
706 862 2302
2001-06-29
David C. Young
Nitrile Powder-Free Medical
Patient Examination Glove
Examination Glove
Examination Glove
Telephone Number:
Contact Person:
Date Summary Prepared:
- NAME OF DEVICE Trade or Proprietary Name:
Common or Usual Name
Classification Name:
Non-Sterile Nitrile Powder-Free Patient
4. DESCRIPTION OF DEVICE
- a. How the device functions: Nitrile rubber films form an excellent barrier to body fluids and bloodborne pathogens.
- b. Scientific concepts that form the basis for the device:
The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing fine movement necessary for treatment. The absence of natural rubber latex in the product yields no latex protein allergens.
- c. Physical and performance characteristics such as design, materials, and physical properties:
Nitrile rubber is known to create a superior barrier to bloodborne pathogens and body fluids.
PAGE 1 OF 3
1
510(K) SUBMISSION FOR BROWN NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 2001-06-29
-
- STATEMENT OF INTENDED USE, INCLUDING DESCRIPTION OF THE DISEASE OR CONDITIONS THAT THE DEVICE WILL ADDRESS This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between the patient and examiner. Powder-free examination gloves are suitable in situations where powder is not desirable.
-
- EXPLANATION OF SIMILARITIES OR DIFFERENCES TO PREDICATE DEVICE
- · The proposed device is identical to the predicate device, except for the following:
The proposed device has been rendered brown in color, like predicate K915086, while predicate K992170 is blue. The cherry flavor in predicate K992170 has been removed and the accelerator/ sulfur mixture in predicate K992170 has been replace with ethylene acrylic acid copolymer.
B. IF SE DECISION BASED ON PERFORMANCE DATA: 1. DISCUSSION OF NON-CLINICAL TESTS
| Specification | Proposed
N-DEX Nitrile Powder-
Free Medical Examination
Glove (brown) | Predicate
N-DEX Nitrile Powder-
Free Medical Examination
Glove (blue) & HPI Brown
Nitrile Surgical Glove |
|--------------------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Performance
Standards | ASTM | ASTM |
| Watertightness | ASTM | ASTM |
| 2. DISCUSSION OF CLINICAL TESTS | | |
| Specification
Safety | Proposed | Predicate |
| Rabbit Irritation | Passes | Passes |
| Guinea Pig Sensitization | Passes | Passes |
| Modified Draze Test
(Human Study) | N/A | Passes (predicate
K992170) |
2
510(K) SUBMISSION FOR BROWN NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 2001-06-29
DISCUSSION OF SAFETY OR EFFECTIVENESS DATA OBTAINED ( with specific reference to adverse effects and complications)
See Section M: Biocompatibility Testing.
3. CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE SAFETY AND EFFECTIVENESS, AND Performance =/> PREDICATE PRODUCT
The Nitrile Powder-Free Medical Examination Glove (brown) 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 "powder-free" medical glove.
Pursuant to 21 C.F.R. 807.87 (j), I David C. Young, Director, Regulatory Affairs and Quality Assurance, 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 the Director, Regulatory Affairs and Quality Assurance, for the Best Manufacturing Company, 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.
David C. Young, Director, Regulatory Affairs & Quality Assurance
2001-06-29 DATE
Young, Director, atory Affairs & Quality Assurance
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 1 2001
Mr. David C. Younq Director of Regulatory Affairs & Quality Assurance Best Manufacturing Company Corporate HeadQuaters 579 Edison Street Menlo, Georgia 30731
Re : K012166 Trade/Device Name: Nitrile Powder-Free Medical Examination Glove (Brown) Requlation Number: 880.6250 Requlatory Class: I Product Code: LZA June 29, 2001 Dated: Received: July 11, 2001
Dear Mr. Young:
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 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory
4
Page 2 - Mr. Young
In addition, FDA may publish further announcements action. 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 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 "Misbranding by reference to the regulation entitled, premarket notification" (21CFR 807.97). 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/dsma/dsmamain.html".
Sincerely yours,
Whitaker
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(K) SUBMISSION FOR BROWN NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 2001-06-29
INDICATIONS FOR USE
Best Manufacturing Company Applicant: 510(k) Number (if known) Device Name: Nitrile Powderical Examination Glove (brown)
The Nitrile Powder-Free Medical Examination Glove (brown) 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).
(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 OR
Over-The-Counter
- For a new submission, do NOT fill in the 510(k) number blank.
Olin S. Lirn
PAGE 3 OF 11
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K012166