(20 days)
Not Found
No
The device description and performance studies focus on the material properties and barrier function of a medical examination glove, with no mention of AI or ML technology.
No
The device, a medical examination glove, is intended to prevent contamination between patient and examiner, not to treat or cure a disease or other health condition.
No
The device is a medical examination glove, which serves as a barrier to prevent contamination, not to diagnose medical conditions.
No
The device description clearly states it is a "Green Nitrile Powder-Free Medical Examination Glove," which is a physical, hardware device made of nitrile rubber.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a glove worn on the examiner's hand to prevent contamination. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body) on specimens like blood, urine, or tissue.
- Device Description: The description focuses on the physical properties of the nitrile rubber as a barrier. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Detecting or measuring substances in the body.
- Providing information for diagnosis, monitoring, or treatment based on laboratory results.
- Mentioning reagents, assays, or analytical methods.
The device is classified under 21 CFR 880.6250, which is the regulation for Patient Examination Gloves. This classification is for medical devices that are physical barriers, not diagnostic tools.
N/A
Intended Use / Indications for Use
The Green 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
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.
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)
DISCUSSION OF NON-CLINICAL TESTS
(Human Study)
Specification: Watertightness
Proposed: ASTM
Predicate: ASTM
DISCUSSION OF CLINICAL TESTS
Specification: Safety
Proposed: Rabbit Irritation - Passes
Predicate: Rabbit Irritation - Passes
Proposed: Guinea Pig Sensitization - Passes
Predicate: Guinea Pig Sensitization - Passes
Proposed: Modified Draze Test - N/A
Predicate: Modified Draze Test - Passes
CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE SAFETY AND EFFECTIVENESS, AND Performance == > PREDICATE PRODUCT
The Nitrile Powder-Free Medical Examination Glove (green) 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.
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
510(K) SUBMISSION FOR GREEN NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (S SUBMISSION DATE: 2001-06-15
SUMMARY OF SAFETY AND EFFECTIVENESS
A. INFORMATION
- 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: | 2001-06-15 |
| 2. NAME OF DEVICE
Trade or Proprietary Name: | Nitrile Powder-Free Medical
Examination Glove (Green) |
| Common or Usual Name | Non-Sterile Nitrile Powder-Free Patient
Examination Glove |
| Classification Name: | Patient Examination Glove |
| 3. PREDICATE DEVICE
IDENTIFICATION NAME | N-DEX Nitrile Powder-Free Medical
Examination Glove, K992170 |
4. DESCRIPTION OF DEVICE
NUMBER
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 vields 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 I OF 3
1
510(K) SUBMISSION FOR GREEN NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 2001-06-15
-
- 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 green in color, while the predicate is blue.
B. IF SE DECISION BASED ON PERFORMANCE DATA: 1. DISCUSSION OF NON-CLINICAL TESTS
(Human Study)
| Specification | Proposed | Predicate |
|---|---|---|
| N-DEX Nitrile Powder-Free Medical Examination Glove (green) | N-DEX Nitrile Powder-Free Medical Examination Glove (blue) | |
| Performance Standards | ASTM | ASTM |
| Watertightness | ASTM | ASTM |
| 2. DISCUSSION OF CLINICAL TESTS | ||
| Specification | Proposed | Predicate |
| Safety | ||
| Rabbit Irritation | Passes | Passes |
| Guinea Pig Sensitization | Passes | Passes |
| Modified Draze Test | N/A | Passes |
PAGE 2 OF 3
2
510(K) SUBMISSION FOR GREEN NITRILE POWDER-FREF. MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 2001-06-15
DISCUSSION OF SAFETY OR EFFECTIVENESS DATA OBTAINED (with specific reference to adverse effects and complications)
See Section M: Biocompatibility Testing.
-
- CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE SAFETY AND EFFECTIVENESS, AND Performance == > PREDICATE PRODUCT
The Nitrile Powder-Free Medical Examination Glove (green) 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.
- CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE SAFETY AND EFFECTIVENESS, AND Performance == > PREDICATE PRODUCT
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. U
David C. Young, Director Regulatory Affairs & Quality Assurance
2001-06-15 DATE
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/2 description: The image contains the words "Public Health Service". The text is in a simple, sans-serif font. The words are arranged on a single line, with "Public Health" on the left and "Service" on the right.
Image /page/3/Picture/3 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol in the center consists of three stylized, curved lines that resemble a stylized human figure.
SEP 1 8 2001
Mr. David C. Young Director of Regulatory Affairs Best Manufacturing Company 579 Edison Street Menlo, Georgia 30731
Re: K012899
Trade/Device Name: Green Nitrile Powder-Free Medical Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: June 15, 2001 Received: August 29, 2001
Dear Mr. Young:
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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4
Page 2 - Mr. Young
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 requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (section 534-542 of the Act; 21); CFR 1000-1050.
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Los A. Walberto
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 GREEN NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 2001-06-15
INDICATIONS FOR USE
Best Manufacturing Company Applicant: 510(k) Number (if known) KO12899 Device Name: Green Nitrile Powder-Free Medical Examination Glove
The Green 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).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
..............................................................................................................................................................................
Concurrence of CDRH Office of Device Evaluation (ODE) ાર Over-The-Counter______________________________________________________________________________________________________________________________________________________________ Prescription Use Per 21 CFR 801.109 * For a new submission, do NOT fill in the 510(k) number blank.
PAGE 3 OF 11
(Division Sign-Off) Division of Dental, Infection Control and General Hospital Devi 510(k) Number .