(49 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and material composition of a medical examination glove. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No
Explanation: A therapeutic device is used to treat a disease or condition. This device is an examination glove, used to prevent contamination, not to treat a medical condition.
No.
The device is described as a patient examination glove used to prevent contamination, not to diagnose a medical condition.
No
The device is a physical examination glove, not a software application. The description focuses on material properties and physical characteristics.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device used externally.
- Device Description: The description details a physical glove made of vinyl, designed for protection and ease of use. There is no mention of analyzing samples from the human body or providing diagnostic information.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose conditions, or monitor treatment. This glove does not perform any such function.
- Performance Studies: The performance studies focus on the physical properties of the glove (freedom from holes, dimensions, irritation, sensitization, powder content), which are relevant to its function as a barrier device, not an IVD.
In summary, the device is a medical examination glove, which is a Class I or Class II medical device used for protection, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
LYZ
Device Description
This product is a powder free, non-sterile, vinyl examination glove that is available in various sizes. The cuff of the glove has been lengthened and the thickness increased to promote use of the glove for procedures where such features are beneficial. It is made with a poly (vinyl 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.
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)
- The gloves meet all ASTM D 5250-99 requirements for freedom from holes, physical properties 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.
The glove is manufactured from a polymer and does not contain any natural rubber latex.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
OCT 1 3 1999
ANNEX V
SUMMARY OF SAFETY AND EFFECTIVENESS K992865
1
Maxxim Medical, Inc. 477 Commerce Blvd. Oldsmar. FL 34677 Phone: 800-727-7951 Fax: 813-855-2290
SUMMARY AND CERTIFICATION MAXXIM MEDICAL SENSICARE™ XP 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 SensiCare™ XP Vinyl Powder Free Examination Gloves. The Maxxim Medical SensiCare™ XP 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 SensiCare™ XP Vinyl Powder Free Examination Gloves are submitted in this 510(k) submission and are summarized as follows:
-
- The gloves meet all ASTM D 5250-99 requirements for freedom from holes, physical properties 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.
- The glove is manufactured from a polymer and does not contain any natural rubber latex. ব
This product is a powder free, non-sterile, vinyl examination glove that is available in various sizes. The cuff of the glove has been lengthened and the thickness increased to promote use of the glove for procedures where such features are beneficial. It is made with a poly (vinyl 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.
Joye T. Moody
Signature of Certifier
Joyce T. Moody
(Typed Name)
Date
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 3 1999
Ms. Joyce T. Moody Vice President Regulatory Affairs/Quality Assurance Maxxim Medical Case Management Division 477 Commerce Blvd. Oldsmar, FL 34677
K992865 Re : SensiCare™ XP Vinyl Powder Free Examination Trade Name: Glove Regulatory Class: I Product Code: LYZ Dated: August 19, 1999 Received: August 25, 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. Existinq major requlations 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
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Page 2 - Ms. Moody
the Federal Register. Please note: this response to your premarket notification 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 regulations.
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 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 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,
Susan Cunnor
imothy 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. |
|---|---|
| ------------ | ---------------------- |
K992845 510(k) Number:
for lick Maxxim Medical SensiCare™ XP Vinyl Powder Free Medical 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 Yes
Qhin S. Lin
(Division Sign-Off) Division of Dental, Infection C and General Hosp 510(k) Number