(71 days)
Not Found
No
The summary describes a medical examination glove made of nitrile rubber and does not mention any AI or ML components or functionalities.
No.
The device is an examination glove, intended to prevent contamination between patient and examiner, not to provide therapy.
No
Explanation: The N-DEX Nitrile Powder-Free Medical Examination Glove is described as a "disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination." Its function is barrier protection, not diagnosis or detection of diseases or conditions.
No
The device description clearly indicates it is a physical glove made of nitrile rubber, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between the patient and examiner." This describes a barrier device used externally.
- Device Description: The description focuses on the physical properties of the glove (material, barrier function, fit) and the absence of powder.
- Lack of IVD Characteristics: An IVD device is typically used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not perform any such function. It is a physical barrier used in vivo (on the body).
- Performance Studies: The performance studies described relate to the physical integrity of the glove (watertightness) and its safety for human contact (irritation and sensitization). These are not the types of performance studies conducted for IVD devices (which would focus on analytical and clinical performance related to detecting or measuring substances).
Therefore, the N-DEX Nitrile Powder-Free Medical Examination Glove is a medical device, but it falls under the category of a barrier device for infection control, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
The N-DEX Nitrile Powder-Free Medical Examination Glove is a disposable device 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
Nitrile rubber films form an excellent barrier to body fluids and bloodborne pathogens. 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. Nitrile rubber is known to create a superior barrier to bloodborne pathogens and body fluids.
The proposed device is identical to the predicate device, except for the following: The proposed device has no donning powder - this has been replaced by a polyurethane base coating, which is fully cross linked with the nitrile film. The proposed device is labeled "Powder-Free".
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
Modified Draze Test (Human Study)
Sample Size: 200 human subjects.
Inclusion Criteria: as discussed in the study, pages 6 and 7, paragraphs 3.11 and 3.12 (see Section M: Human and Animal Testing).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests:
Performance Standards: ASTM
Watertightness: ASTM
Clinical Tests:
Rabbit Irritation: Passes
Guinea Pig Sensitization: Passes
Modified Draze Test (Human Study): Passes
Key Results: The N-DEX 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 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
K99217$\phi$
SEP 7 1999
510(K) SUBMISSION FOR N-DEX NITRILE POWDER-FREE MEDICAL EXAMINATION GLO SUBMISSION DATE: 1999-06-16
SUMMARY OF SAFETY AND EFFECTIVENESS
A. INFORMATION 1. SUBMITTER'S Name: BEST MANUFACTURING COMPANY Address: 579 Edison Street Menlo, GA 30731 USA Telephone Number: 706 862 2302 Contact Person: David C. Young Date Summary Prepared: 1999-06-16 2. NAME OF DEVICE Trade or Proprietary Name: N-DEX Nitrile Powder-Free Medical Examination Glove Common or Usual Name Non-Sterile Nitrile Powder-Free Patient Examination Glove Classification Name: Patient Examination Glove 3. PREDICATE DEVICE N-DEX, K902696 IDENTIFICATION NAME. NUMBER 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 N-DEX NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 1999-06-16
5. 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.
6. 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 no donning powder - this has been replaced by a polyurethane base coating, which is fully cross linked with the nitrile film.
The proposed device is labeled "Powder-Free".
B. IF SE DECISION BASED ON PERFORMANCE DATA: 1. DISCUSSION OF NON-CLINICAL TESTS
| Specification | Proposed
N-DEX Nitrile Powder-
Free Medical Examination
Glove | Predicate
N-DEX |
|--------------------------------------|------------------------------------------------------------------------|--------------------|
| Performance Standards | ASTM | ASTM |
| Watertightness | ASTM | FDA |
| 2. DISCUSSION OF CLINICAL TESTS | | |
| Specification
Safety | Proposed | Predicate |
| Rabbit Irritation | Passes | N/A |
| Guinea Pig Sensitization | Passes | N/A |
| Modified Draze Test
(Human Study) | Passes | N/A |
DESCRIPTION OF SUBJECTS
For the Modified Draze Test, 200 human subjects were used. The criteria for inclusion in the study was as discussed in the study, pages 6 and 7, paragraphs 3.11 and 3.12 (see Section M: Human and Animal Testing). PAGE 2 OF 3
2
510(K) SUBMISSION FOR N-DEX NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 1999-06-16
DISCUSSION OF SAFETY OR EFFECTIVENESS DATA OBTAINED ( with specific reference to adverse effects and complications)
See Section M: Human and Animal Testing, page 4 "SUMMARY", of the Modified Draze Test.
-
- CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE SAFETY AND EFFECTIVENESS, AND Performance =/> PREDICATE PRODUCT
The N-DEX 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 nonclinical tests and satisfies the requirements for a safe and effective "powder-free" medical glove.
- CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE SAFETY AND EFFECTIVENESS, AND Performance =/> PREDICATE PRODUCT
Pursuant to 21 C.F.R. 807.87 (i), 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 (l
1999-06-16
David C. Young, Director, Rep Jalatory Affairs & Quality Assurance DATE
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the department's name encircling a central graphic. The graphic features a stylized representation of a human figure, composed of three overlapping profiles facing to the right, suggesting a sense of community and support.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP | 7 | 1999
Mr. David C. Young Director, Regulatory Affairs & Quality Assurance Best Manufacturing Company 579 Edison Street Menlo, Georgia 30731
K992170 Re : N-DEX Blue Powder-Free Nitrile Medical Trade Name: Examination Glove Requlatory Class: I Product Code: LZA Dated: June 16, 1999 Received: June 28, 1999
Dear Mr. Young:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marree is substantially equivalent (for the indications for use stated in the enclosure) to 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 The general controls provisions of the Act 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. ರ್ಥ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements 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
4
Page 2 - Mr. Young
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 the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Tim Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
5
જ
S IO(K) SUBMISSION FOR N-DEX NTTRILE POWDER-FREE MEDICAL EXAMINATION GALO SUBMISSION DATE: 1999-06-16
INDICATIONS FOR USE
Best Manufacturing Company Applicant: 510(k) Number (if known) 510(K) Name: N-DEX Nitrile Powder-Free Medical Examination Glove
The N-DEX Nitrile Powder-Free Medical Examination Glove is a disposable The N-DEA Nittle Fower Tree Inc. I receins 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
PAGE 3 OF 11
ums. 5. Lin
(Division Sign-Off)
Division
Sign-Off Sign-Off)
Division of Dental, Infection Control,
and General Hospital, Devis and General Hospital 510(k) Number