(81 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
This product is a powder free, non-sterile, polyurethane examination glove that is available in various sizes. It is made with a polyurethane polymer and a polyurethane coating on the user side. This coating provides good donning and doffing without the use of donning powder. No release powder or chemical release agents are used. The gloves will be marketed both as medical examination gloves and dental examination gloves.
Acceptance Criteria and Device Performance for Maxxim Medical Polyurethane Powder Free Medical/Dental Examination Gloves
This document summarizes the acceptance criteria and the study results demonstrating that the Maxxim Medical Polyurethane Powder Free Medical/Dental Examination Gloves meet these criteria, as presented in the provided 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| ASTM D 3578-95 Requirements | |
| - Freedom from holes | Met |
| - Physical properties (except ultimate elongation before aging) | Met (explicitly states "except ultimate elongation before aging" for the D 3578-95 requirements, implying other physical properties were met) |
| - Physical dimensions | Met |
| ISO 10993-Part 10 Requirements | |
| - Non-irritating and non-sensitizing | Met (tested in accordance with ISO10993-Part 10 and shown to be non-irritating and non-sensitizing) |
| ASTM D 6124-97 Requirements | |
| - Labeling as powder free | Met (device meets requirements for labeling as powder free; "No powders are utilized in the manufacture of this glove.") |
| Does not contain natural rubber latex | Met (the glove is manufactured from a polymer and does not contain any natural rubber latex) |
| Physical properties and dimensions for medical/dental examination uses (compared to predicate devices) | Met (All requirements for physical properties and dimensions have been met for such uses, based upon comparisons to the predicate devices: Nitra-Touch™ Nitrile Powder Free Medical Examination gloves (K965095) and SensiCare™ Powder Free Vinyl Medical Examination gloves (K944182). Specific data not provided in summary.) |
| Polyurethane coating provides good donning and doffing without donning powder, release powder, or chemicals | Implied Met (the polyurethane coating on the user side provides good donning and doffing without the use of donning powder; "No release powder or chemical release agents are used.") |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the exact sample sizes used for the testing. It generally states that "The results of the safety, efficacy and performance testing of the Polyurethane Powder Free Examination Gloves are submitted in this 510(k) submission." The tests appear to be primarily retrospective, as they involve testing manufactured gloves against established standards. The data provenance is implied to be from testing conducted by or for Maxxim Medical, Inc. in the United States (given the submission to the FDA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Based on the information provided, no "experts" in the sense of clinical specialists or radiologists were used to establish ground truth. The "ground truth" for the performance criteria is defined by industry standards (ASTM, ISO). Compliance with these standards is typically assessed through laboratory testing and measurement by trained technicians and engineers, rather than expert interpretation of medical images or conditions.
4. Adjudication Method for the Test Set
No adjudication method is mentioned. The assessment of compliance with standard specifications (e.g., freedom from holes, physical properties) is typically objective and based on direct measurement or established test protocols with defined acceptable limits, not on subjective expert opinion requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or mentioned. This is not applicable to a device like examination gloves, which are assessed based on physical and material properties, not diagnostic interpretation.
6. Standalone Performance Study
Yes, a standalone performance study was conducted. The device (the glove itself, an "algorithm" is not applicable here) was tested to directly assess its compliance with various standards (ASTM D 3578-95, ISO 10993-Part 10, ASTM D 6124-97) and its physical properties. This testing was performed independent of human-in-the-loop interaction for the specific performance parameters mentioned.
7. Type of Ground Truth Used
The ground truth used is primarily objective industry standards and test specifications (ASTM D 3578-95, ISO 10993-Part 10, ASTM D 6124-97). Additionally, a form of ground truth is established by comparison to predicate devices (K965095 and K944182) for overall physical properties and dimensions.
8. Sample Size for the Training Set
Not applicable. This device is a physical product (medical glove), not a machine learning algorithm. Therefore, there is no "training set" in the context of AI. The manufacturing process and formulation could be considered the "training" in a very loose sense, but that's not what is typically meant by a training set in medical device submissions related to AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device. The design and manufacturing processes are likely informed by years of experience in glove production, material science, and feedback from existing products, which could be seen as an iterative development process but not a formal "training set" with established ground truth labels for an algorithm.
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JUL 29 1999
Maxxim Medical, Inc. 477 Commerce Blvd. Oldsmar, FL 34677 Phone: 800-727-7951 Fax: 813-855-2290
Amended 7-13-99 K991615
SUMMARY AND CERTIFICATION MAXXIM MEDICAL POLYURETHANE POWDER FREE MEDICAL/DENTAL EXAMINATION GLOVES
Class I (classification by the General Hospital and Personal Use Device Panel)
Common Name: Medical Examination Gloves Dental Examination Gloves
Classification Name: Patient Examination Glove (21 CFR 880.6250)
The purpose of this 510(k) is to obtain an FDA clearance for manufacturing and distributing Polyurethane Powder Free Examination Gloves. The Maxxim Medical Powder Free Polyurethane Medical/Dental Examination glove is substantially equivalent to the Nitra-Touch™ Nitrile Powder Free Medical Examination gloves and SensiCare™ Powder Free Vinyl Medical Examination gloves, originally cleared under K965095 and K944182 respectively. The results of the safety, efficacy and performance testing of the Polyurethane Powder Free Examination Gloves are submitted in this 510(k) submission and are summarized as follows:
- The gloves meet all ASTM D 3578-95 requirements for freedom from holes, physical properties 1. and physical dimensions, except ultimate elongation before aging.
- The gloves have been tested and have been shown to be non-irritating and non-sensitizing when 2. tested in accordance with ISO10993-Part 10.
- The gloves meet requirements of ASTM D 6124-97 for labeling as powder free. No powders are ന് utilized in the manufacture of this glove.
-
- The glove is manufactured from a polymer and does not contain any natural rubber latex.
This product is a powder free, non-sterile, polyurethane examination glove that is available in various sizes. It is made with a polyurethane polymer and a polyurethane coating on the user side. This coating provides good donning and doffing without the use of donning powder. No release powder or chemical release agents are used. The gloves will be marketed both as medical examination gloves and dental examination gloves. All requirements for physical properties and dimensions have been met for such uses, based upon comparisons to the predicate devices.
Oyse T. Mordy
Signature of Certifier
Jovce T. Moodv (Typed Name)
7-13-99
Date
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three curved lines that resemble a person with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 29 1999
Ms. Joyce T. Moody Vice President Requlatory Affairs/Quality Assurance Maxxim Medical, Incorporated 477 Commerce Boulevard Oldsmar, Florida 34677
Re: K991615 Polyurethane Powder Free Medical/Dental Trade Name: Examination Glove Requlatory Class: I Product Code: LZA Dated: May 7, 1999 Received: May 10, 1999
Dear Ms. Moody:
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 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 Requlations, 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister.
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Page 2 - Ms. Moody
this response to your premarket notification Please note: 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 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 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
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
Applicant:
Maxxim Medical, Inc.
1615
510(k) Number:
Maxxim Medical Polyurethane Powder Free Medical/Dental Examination Gloves Device Name:
Indications for Use:
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
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 Over the Counter
Qiu S. Lin
(Division Sion-OH) Division of Dental, Infection Cor and General Hospit 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.