(56 days)
Not Found
No
The device description and intended use clearly describe a physical barrier device (examination glove) with no mention of software, algorithms, or AI/ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device, a nitrile glove, is intended to prevent contamination between the patient and examiner, serving as a barrier rather than providing a therapeutic effect.
No
The device is described as an examination glove intended to prevent contamination, not to diagnose conditions.
No
The device description clearly states it is a physical glove made of nitrile rubber, intended to be worn on the hand. It is a tangible hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "worn on the examiner's hand to prevent contamination between the patient and examiner." This is a barrier device for personal protection, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the physical properties of the glove (barrier to fluids, tensile properties, absence of latex allergens) and its function as a barrier. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring analytes
The device described is a medical examination glove, which falls under a different regulatory classification than IVDs. The provided CFR reference (21 CFR 880.6250) also confirms this, as it pertains to "Patient examination glove."
N/A
Intended Use / Indications for Use
The Nitrile Powder-Free Medical Examination Glove (blue) 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
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.
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 included performance standards and watertightness, both tested to ASTM. Clinical tests included rabbit irritation and guinea pig sensitization, both of which "Passes". The device was compared to a legally marketed predicate device, and data summaries indicated 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 BLUE NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 2002-12-24 SUMMARY OF SAFETY AND EFFECTIVENESS
A. INFORMATION
- SUBMITTER'S Name:
Address:
BEST MANUFACTURING COMPANY
579 Edison Street Menlo, GA 30731 USA
706 862 2302
David C. Young
Examination Glove
Telephone Number:
Contact Person:
Date Summary Prepared: 2002-12-24
-
- NAME OF DEVICE Nitrile Powder-Free Medical Trade or Proprietary Name:
Common or Usual Name
- NAME OF DEVICE Nitrile Powder-Free Medical Trade or Proprietary Name:
Non-Sterile Nitrile Powder-Free Patient Examination Glove
Classification Name: Patient Examination Glove
- Blue Nitrile Powder-Free Medical 3. PREDICATE DEVICE Examination Glove, K992170; and IDENTIFICATION NAME, NUMBER Nitrile Powder-Free Medical Examination Glove (brown), K012166
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 BLUE NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 2002-12-240
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.
-
- EXPLANATION OF SIMILARITIES OR DIFFERENCES TO PREDICATE DEVICE
- · The proposed device is identical to the predicate device, except for the following:
The formula for the modified device does not contain the cherry flavor and the accelerator/sulfur mixture as found in the predicate K992170. The cherry flavor has been eliminated completely, with no replacement. The accelerator/sulfur mixture has been replaced by WE4-25A ethylene acrylic acid copolymer, as used in predicate K012166.
B. IF SE DECISION BASED ON PERFORMANCE DATA: 1. DISCUSSION OF NON-CLINICAL TESTS
| Specification | Proposed
Nitrile Powder-Free
Medical Examination
Glove (blue), textured
and non-textured | Predicate
Blue Nitrile Powder-Free
Medical Examination
Glove & Nitrile Powder-Free
Medical Examination Glove
(brown) |
|---------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| 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 | N/A |
PAGE 2 OF 3
2
510(K) SUBMISSION FOR BLUE NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 2002-12-24
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 (blue) 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 Ouality 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
2002-12-24
DATE
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. The logo is black and white.
Public Health Service
MAR 0 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David C. Young Director, Regulatory Affairs & Quality Assurance Best Manufacturing Company 579 Edison Street Menlo, Georgia 30731
Re: K030075
Trade/Device Name: Nitrile Powder-Free Medical Examination Gloves, Blue Textured and Non-textured Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: December 24, 2002 Received: January 8, 2003
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.
4
Page 2 - Mr. Young
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 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 Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Susan Rempen
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(K) SUBMISSION FOR BLUE NTTRILE POWDER-FREE MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 2002-12-24
INDICATIONS FOR USE
Applicant: Best Manufacturing Company 510(k) Number (if known) Device Name: Nitrile Powder-Free Medical Examination Glove (blue) Textured of Nortextured The Nitrile Powder-Free Medical Examination Glove (blue) 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. Lim
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division of Ancol. Dental Devices
510(k) Number. K030025
PAGE 3 OF 11