(22 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, vinyl examination glove that is available in various sizes. It is made with a poly (viny) Chloride) 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 as medical examination gloves.
The provided text describes the regulatory clearance for Maxxim Medical's Tru-Touch™ PF Vinyl Powder Free Medical Examination Gloves. It focuses on demonstrating substantial equivalence to a previously cleared device (SensiCare™ Powder Free Vinyl Medical Examination gloves, K944182) rather than conducting a new comprehensive study with detailed acceptance criteria and performance data for a novel device.
As such, many of the requested elements for a study proving device meets acceptance criteria are not present in this type of submission. This document is a 510(k) premarket notification for a Class I medical device, which primarily relies on demonstrating substantial equivalence to a predicate device.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (ASTM/ISO Standards) | Reported Device Performance |
|---|---|
| Freedom from holes, physical properties, and physical dimensions (ASTM D 5250-92 requirements) | "The gloves meet all ASTM D 5250-92 requirements for freedom from holes, physical properties and physical dimensions." (Explicitly stated as met, specific values/metrics for "freedom from holes, physical properties, and physical dimensions" are not detailed in this summary for the Tru-Touch™ PF Vinyl gloves. It's implied they meet the standard's specifications.) |
| Non-irritating and non-sensitizing (ISO10993-Part 10) | "The gloves have been tested and have been shown to be non-irritating and non-sensitizing when tested in accordance with ISO10993-Part 10." (Explicitly stated as met.) |
| Powder-free labeling (ASTM D 6124-97) | "The gloves meet requirements of ASTM D 6124-97 for labeling as powder free. No powders are utilized in the manufacture of this glove." (Explicitly stated as met. This also aligns with the "Powder Free" in the device name.) |
| Does not contain any natural rubber latex | "The glove is manufactured from a polymer and does not contain any natural rubber latex." (Explicitly stated as met. This is a material specification rather than a performance test, but it's a key characteristic.) |
| Physical properties and dimensions for medical examination glove intended use (implied, not a specific standard listed here but generally covered by ASTM D 5250-92) | "All requirements for physical properties and dimensions have been met for this intended use [medical examination gloves]." (General statement of compliance.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size used for testing against ASTM and ISO standards. Standard test methods usually define required sample sizes, but these are not disclosed in this summary.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for a physical product like a glove, it's highly likely the testing was prospective (i.e., new tests were performed on the Tru-Touch™ PF Vinyl gloves).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable to the evaluation of medical examination gloves against material and performance standards. Ground truth for these criteria is established by objective, standardized laboratory tests (e.g., tensile strength, elongation, pinhole detection, chemical irritation tests), not by expert consensus on interpretations.
4. Adjudication Method for the Test Set
- Not applicable for the types of tests described. Results for physical and chemical properties are typically quantitative or pass/fail based on established standard thresholds, not subject to human adjudication in the way, for example, image interpretation or clinical outcomes might be.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices (e.g., imaging software) where human readers interpret results, and the AI's impact on their performance is evaluated. This is not relevant for medical examination gloves.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-based device. The "performance" being discussed relates to the glove's physical and chemical properties.
7. The Type of Ground Truth Used
- The ground truth for the performance criteria (e.g., freedom from holes, physical properties, non-irritation) is based on objective, standardized test methods and established thresholds defined within the referenced ASTM and ISO standards (e.g., ASTM D 5250-92, ISO 10993-Part 10, ASTM D 6124-97). These are laboratory-based, quantitative assessments.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of physical medical examination gloves. This term typically refers to data used to train machine learning algorithms.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set for this device.
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Maxxim Medical, Inc. 477 Commerce Blvd. Oldsmar. FL 34677 Phone: 800-727-7951 Fax: 813-855-2290
SUMMARY AND CERTIFICATION MAXXIM MEDICAL TRU-TOUCH™ PF VINYL POWDER FREE MEDICAL EXAMINATION GLOVES
Class I (classification by the General Hospital and Personal Use Device Panel)
Common Name: Medical 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 Tru-Touch™ PF Vinyl Powder Free Examination Gloves. The Maxxim Medical Tru-Touch™ PF Vinyl Powder Free Medical Examination glove is substantially equivalent to the SensiCare™ Powder Free Vinyl Medical Examination gloves, originally cleared under K944182. The results of the safety, efficacy and performance testing of the Tru-Touch™ PF Vinyl Powder Free Examination Gloves are submitted in this 510(k) submission and are summarized as follows:
- The gloves meet all ASTM D 5250-92 requirements for freedom from holes, physical properties 1. and physical dimensions.
-
- The gloves have been tested and have been shown to be non-irritating and non-sensitizing when tested in accordance with ISO10993-Part 10.
-
- The gloves meet requirements of ASTM D 6124-97 for labeling as powder free. No powders are utilized in the manufacture of this glove.
- ব The glove is manufactured from a polymer and does not contain any natural rubber latex.
This product is a powder free, non-sterile, vinyl examination glove that is available in various sizes. It is made with a poly (viny) Chloride) 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 as medical examination gloves. All requirements for physical properties and dimensions have been met for this intended use.
Joyce T. Moody
Signature of Certifier
Joyce T. Moody
(Typed Name)
June 21, 1999
Date
28
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them that resemble waves or fabric.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 15 1999
Ms. Joyce T. Moody Vice President Regulatory Affairs/Quality Assurance Maxxim Medical, Incorporated 477 Commerce Boulevard Oldsmar, Florida 34677
Re : K992122 Tru-Touch™ PF Vinyl Powder Free Examination Trade Name: Glove Requlatory Class: I Product Code: LYZ Dated: June 21, 1999 June 23, 1999 Received:
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 aqainst 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. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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.
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Page 2 - Ms. Moody
Please note: this response to your premarket notification Please note: this reportion ou folligation you might have under submission docb not arross and one for devices under the sections 551 chrough 315 control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as Inis recei will arrow foaremarket notification. The FDA described in your 510 m, promalence of your device to a legally Finding of Subscancial equiralist in a classification for your marketed predicate as to 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 compriance as (advertising of your device, please contact the Dffice of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
the regulation entitled, "Misbranding by reference to information on your responsibilities under the Act may be Information on your copien of Small Manufacturers Assistance obtained from the Divibion (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fday.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. |
|---|---|
| 510(k) Number: | K992122 |
| Device Name: | Maxxim Medical Tru-Touch PF Vinyl Powder Free Medical Examination Gloves |
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 Yes __
Chun S. Lin
(Division Sign-Off) Division of Dental, Infec and General Hospita 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.