(122 days)
The NITRI-CARE Nitrile Powder-Free Sterile 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).
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.
Acceptance Criteria and Study for NITRI-CARE Nitrile Powder-Free Sterile Medical Examination Glove
The provided document describes the acceptance criteria and a study to demonstrate the substantial equivalence of the NITRI-CARE Nitrile Powder-Free Sterile Medical Examination Glove to a predicate device (N-DEX Nitrile Powder-Free Medical Examination Glove, K992170). The focus of the substantiation is on the safety and performance characteristics, particularly concerning watertightness, irritation, and sensitization.
1. Table of Acceptance Criteria and Reported Device Performance
| Specification/Test | Acceptance Criteria | Reported Device Performance (Proposed Device) | Predicate Device Performance |
|---|---|---|---|
| Performance Standards | ASTM (for examination gloves) | Meets ASTM standards | Meets ASTM standards |
| Watertightness | ASTM (for examination gloves) | Meets ASTM standards | Meets ASTM standards |
| Safety - Rabbit Irritation | Passes (standard animal irritation test) | Passes | Passes |
| Safety - Guinea Pig Sensitization | Passes (standard animal sensitization test) | Passes | Passes |
| Safety - Modified Draze Test (Human Study) | Passes (no significant irritation/sensitization) | Passes | Passes (implied by substantial equivalence claim) |
Note: The document explicitly states, "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." This implies that the proposed device's performance aligns with or is better than the predicate's according to the established acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Modified Draze Test (Human Study): 200 human subjects.
- Data Provenance: The document does not explicitly state the country of origin for the human study. The study appears to be prospective as it involved testing human subjects for the device's safety. The animal tests (Rabbit Irritation, Guinea Pig Sensitization) are also typically prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications for establishing the "ground truth" (i.e., assessment of "Passes" for irritation and sensitization tests). These are standard biological evaluation tests whose interpretation would typically be performed by trained personnel in a testing facility, following established protocols for interpreting skin reactions.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. Interpretation of animal and human skin patch tests often involves standardized grading scales and expert evaluation, but the submission doesn't detail any specific multi-reader adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was conducted or is mentioned. The device is a medical examination glove, and its effectiveness is primarily assessed through barrier integrity (watertightness) and biological safety (lack of irritation/sensitization), not through efficacy in complex diagnostic or therapeutic tasks requiring human interpretation of data. Therefore, a study assessing human reader improvement with or without AI assistance is not applicable to this device.
6. Standalone (Algorithm Only) Performance Study
No standalone performance study was conducted or is mentioned. This device does not involve an algorithm or AI component. Its performance is based on its physical and chemical properties and biological safety.
7. Type of Ground Truth Used
The ground truth for the performance and safety tests is based on pre-defined pass/fail criteria for standardized tests:
- Performance (Watertightness): Adherence to ASTM standards, which specify methods and criteria for determining watertightness.
- Safety (Irritation/Sensitization - Animal & Human): Observation and grading of biological responses (e.g., skin reactions) against established criteria inherent in the "Passes" outcome for tests like Rabbit Irritation, Guinea Pig Sensitization, and Modified Draze Test. This aligns with physiological/biological response data interpreted against normative standards.
8. Sample Size for the Training Set
Not applicable. This device is a passive barrier (medical glove) and does not involve any machine learning algorithm that would require a "training set."
9. How Ground Truth for the Training Set Was Established
Not applicable. As stated above, there is no training set for this type of device.
{0}------------------------------------------------
MAR 10 2000 K993805
510(K) SUBMISSION FOR NITRI-CARE NITRILE POWDER-FREE STERILE MEDICAL EXAMINATION GLOVE
SUBMISSION DATE: 1999-11-08
SUMMARY OF SAFETY AND EFFECTIVENESS
A. INFORMATION
| 1. SUBMITTER'S Name: | BEST MANUFACTURING COMPANY |
|---|---|
| Address: | 579 Edison StreetMenlo, GA 30731 USA |
| Telephone Number: | 706 862 2302 |
| Contact Person: | David C. Young |
| Date Summary Prepared: | 1999-11-08 |
| 2. NAME OF DEVICE | |
| Trade or Proprietary Name: | NITRI-CARE Nitrile Powder-Free SterileMedical Examination Glove |
| Common or Usual Name | Sterile Nitrile Powder-Free PatientExamination Glove |
| Classification Name: | Patient Examination Glove |
| 3. PREDICATE DEVICE | |
| IDENTIFICATION NAME, NUMBER | N-DEX Nitrile Powder-Free MedicalExamination Glove, K992170 |
- 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 NITRI-CARE NITRILE POWINER-FREE STERILE MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 1999-11-08
-
- 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. Sterile gloves are suitable where a sterile examination glove is required.
-
- EXPLANATION OF SIMILARITIES OR DIFFERENCES TO PREDICATE DEVICE
- · The proposed device is identical to the predicate examination glove K992170 device, except for the following: The proposed device is labelled "Sterile".
B. IF SE DECISION BASED ON PERFORMANCE DATA: 1. DISCUSSION OF NON-CLINICAL TESTS
2
| Specification | ProposedNITRI-CARE NitrilePowder-Free SterileMedical ExaminationGlove | PredicateN-DEX NitrilePowder-Free MedicalExamination Glove |
|---|---|---|
| PerformanceStandards | ASTM | ASTM |
| Watertightness | ASTM | ASTM |
| 2. DISCUSSION OF CLINICAL TESTS | ||
| SpecificationSafety | Proposed | Predicate |
| Rabbit Irritation | Passes | Passes |
| Guinea Pig Sensitization | Passes | Passes |
| Modified Draze Test(Human Study) | Passes | Passes |
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 N: Human and Animal Testing).
PAGE 2 OF 3
{2}------------------------------------------------
DISCUSSION OF SAFETY OR EFFECTIVENESS DATA OBTAINED (with specific reference to adverse effects and complications)
See Section N: Human and Animal Testing, page 4 "SUMMARY", of the Modified Draze Test.
3. CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE SAFETY AND EFFECTIVENESS, AND Performance =/> PREDICATE PRODUCT
The NITRI-CARE Nitrile Powder-Free Sterile 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.
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
1999-11-08
DATE
David C. Young, Director, Regulatory Affairs & Quality Assurance
PAGE 3 OF 3
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which consists of a stylized caduceus symbol with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 0 2000
Mr. David C. Younq Director, Requlatory Affairs & Quality Assurance Best Manufacturing Company 579 Edison Street Menlo, Georgia 30731-0008
Re : K993805 Trade Name: NITRI-CARE Nitrile Powder-Free Sterile Medical Examination Glove, Blue, Cherry-Flavored Regulatory Class: I Product Code: LZA Dated: February 15, 2000 Received: February 22, 2000
Dear Mr. Younq:
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 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 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 regulation may result in regulatory 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
{4}------------------------------------------------
Paqe 2 - Mr. Younq
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. 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.fdaggov/cdrh/dsmamain.html".
Sincerely yours,
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 NITRI-CARE NITRILE POWDER-FREE STERILE MEDICAL EXAMINATION GLOVE SUBMISSION DATE: 1999-11-08
INDICATIONS FOR USE
Applicant: Best Manufacturing Company 510(k) Number (if known) Device Name: NITRI-CARE Nitrile Powder-Free Sterile Medical Examination Glove . avore
The NITRI-CARE Nitrile Powder-Free Sterile 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)
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 Silin
PAGE 3 OF 11
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dev 510(k) Number
§ 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.