(267 days)
Not Found
No
The device is a physical examination glove and the description focuses on its material and donning properties, with no mention of AI or ML.
No
The device, examination gloves, is intended to prevent contamination between patient and examiner, not to treat or diagnose a medical condition.
No
Explanation: The device, Glide-On Vinyl Examination Gloves, is described as being "worn on the examiner's hands or fingers to prevent contamination between patient and examiner." This indicates its purpose is protective and hygienic during examinations, not to diagnose medical conditions by analyzing patient data or body functions.
No
The device is a physical product (gloves) made of polyvinyl chloride (PVC) and polyurethane, not software.
Based on the provided information, the Glide-On Vinyl Examination Gloves are not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is clearly stated as being worn on the examiner's hands or fingers to prevent contamination between patient and examiner. This is a barrier function for personal protection and infection control, not a diagnostic test performed on a sample from the body.
- Device Description: The description focuses on the physical properties of the glove (material, coating, size, sterility) and its function as a barrier. There is no mention of any components or processes related to analyzing biological samples.
- Lack of Diagnostic Elements: There are no mentions of analyzing bodily fluids, tissues, or any other biological samples to diagnose a condition, monitor a disease, or determine compatibility.
- Performance Studies: The performance studies described focus on biocompatibility, frictional properties, and ease of donning. These are relevant to the glove's function as a barrier and protective device, not to diagnostic accuracy.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment decisions. The Glide-On Vinyl Examination Gloves do not fit this description.
N/A
Intended Use / Indications for Use
The Glide-On Vinyl Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LYZ
Device Description
The Glide-On Vinyl Examination Gloves are single use only, disposable gloves intended for medical purposes to be worn on the hands or fingers of examiners. The gloves are powder-free and are made of poly vinyl chloride (PVC) with an inner coating of polyurethane. This inner polyurethane coating acts as a lubricant to aid in the donning of the gloves when hands are wet, damp or dry. The gloves are offered nonsterile and are available in small, medium, large and extra large sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or fingers
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
An evaluation was performed comparing the frictional properties of the Glide-On Vinyl Examination Gloves to a plain vinyl glove. The testing was performed per ASTM D1894, Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting. Both gloves were tested under wet and dry conditions.
A user study involving one hundred seventy (170) subjects was also performed to evaluate the ease of glove donning on damp hands and dry hands compared to three other vinyl gloves coated with polyurethane. The study evaluated the amount of time it took each glove and also the amount of glove tears that occurred during the donning of each glove.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The biocompatibility evaluation for the Glide-On Vinyl Examination Gloves was conducted in accordance with ANSVAAMVISO 10993-1:2009 Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by FDA. The Glide-On Vinyl Examination Gloves are classified as a surface contacting device with a limited contact duration of less than 24 hours.
The following tests were performed to evaluate the biocompatibility of the Glide-On Vinyl Examination Glove:
- ISO 10993-10: Irritation Intracutaneous reactivity
- ISO 10993-10: Delayed-Type Hypersensitivity (Sensitization) Buehler Test
An evaluation was performed comparing the frictional properties of the Glide-On Vinyl Examination Gloves to a plain vinyl glove. The testing was performed per ASTM D1894, Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting. Both gloves were tested under wet and dry conditions.
A user study involving one hundred seventy (170) subjects was also performed to evaluate the ease of glove donning on damp hands and dry hands compared to three other vinyl gloves coated with polyurethane. The study evaluated the amount of time it took each glove and also the amount of glove tears that occurred during the donning of each 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 22, 2016
Medline Industries, Inc. Jennifer Mason Senior Regulatory Affairs Specialist One Medline Place Mundelein, IL 60060
Re: K151754
Trade/Device Name: Glide-On Vinyl Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: February 22, 2016 Received: February 23, 2016
Dear Ms. Mason:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements
1
as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151754
Device Name Glide-On Vinyl Examination Gloves
Indications for Use (Describe)
The Glide-On Vinyl Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the Medline logo. The logo features the word "MEDLINE" in white, bold sans-serif font, positioned to the left of a white, stylized starburst symbol. The background is a solid dark blue color. The logo is simple, clean, and easily recognizable.
ledline Industries, Inc. One Medline Place Mundelein, IL 60060
510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]
Submitter / 510(k) Sponsor
Medline Industries, Inc. 1 Medline Place Mundelein, IL 60060
Registration Number: 1417592
Contact Person
Jennifer Mason Senior Regulatory Affairs Specialist Phone: 847-643-3652 Email: jamason@medline.com
Summary Preparation Date March 21, 2016
Type of 510(k) Submission Traditional
Device Name / Classification
Name of Device: Glide-On Vinyl Examination Gloves Proprietary Name: Glide-On Vinyl Examination Gloves Common Name: Vinyl Patient Examination Glove Classification Name: Patient Examination Glove Product Code: LYZ Product Class: Class I Regulation #: 21 CFR 880.6250 Classification Panel: General Hospital
Predicate Device
Powder-Free PVC Vinyl Patient Examination Glove, Clear (non-colored) K142703
Device Description
The Glide-On Vinyl Examination Gloves are single use only, disposable gloves intended for medical purposes to be worn on the hands or fingers of examiners. The gloves are powder-free and are made of poly
4
Image /page/4/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is in white, sans-serif font, and to the right of the text is a white, stylized star shape that resembles a medical cross.
edline Industries. One Medline Place Mundelein II 60060
vinyl chloride (PVC) with an inner coating of polyurethane. This inner polyurethane coating acts as a lubricant to aid in the donning of the gloves when hands are wet, damp or dry. The gloves are offered nonsterile and are available in small, medium, large and extra large sizes.
Indications for Use
The Glide-On Vinyl Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
Summary of Technological Characteristics
The Glide-On Vinyl Examination Gloves are substantially equivalent to the predicate, K142703. Both gloves have the same intended use, same material and the same device performance.
| Device Characteristic | Proposed Device | Predicate Device | Comparison
Analysis |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Glide-On Vinyl
Examination Gloves | Powder-free PVC Vinyl
Exam Gloves | N/A |
| 510(k) Reference | | K142703 | N/A |
| Product Owner | Medline Industries, Inc | Hebei Grandeast Plastic
Products Co., Ltd. | Different |
| Product Code | LYZ | LYZ | Same |
| Intended Use | The Glide-On Vinyl
Examination Gloves are
disposable device intended
for medical purposes that
are worn on the examiner's
hands or fingers to prevent
contamination between
patient and examiner. | The powder-free PVC vinyl
exam gloves are disposable
devices intended for
medical purposes that are
worn on the examiner's
hands or fingers to prevent
contamination between
patient and examiner. | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Sizes | Small
Medium
Large
Extra-Large | Small
Medium
Large
Extra-Large | Same |
| Materials | PVC
Lubricant - Polyurethane
with a viscosity up to 18
centipoise | PVC
Lubricant - Polyurethane
with a viscosity up to 4.6
centipoise | Similar |
| Dimensions - Length | Complies with ASTM
D5250-06 (reapproved) | Complies with ASTM
D5250-06 (reapproved) | Same |
TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES
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Image /page/5/Picture/0 description: The image features the Medline logo, which is set against a blue background. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a white, stylized starburst or cross-like symbol. The symbol is oriented diagonally, with its points extending outwards from the center. The overall design is clean and corporate, conveying a sense of professionalism and reliability.
Medline Industries, Inc. One Medline Place Mundelein, IL 60060
| 2011) ≥230mm | 2011) ≥230mm | ||
|---|---|---|---|
| Dimensions - Width | Complies with ASTM | ||
| D5250-06 (reapproved |
Small - 85±5mm
Medium - 95±5mm
Large - 105±5mm
Extra Large - 115±5mm | Complies with ASTM
D5250-06 (reapproved
2011)
Small - 85±5mm
Medium - 95±5mm
Large - 105±5mm
Extra Large - 115±5mm | Same |
| Dimensions - Thickness | Complies with ASTM
D5250-06 (reapproved
2011)
Palm - 0.10±0.02mm
Finger - 0.10±0.02mm | Complies with ASTM
D5250-06 (reapproved
2011)
Palm - 0.10±0.02mm
Finger - 0.10±0.02mm | Same |
| Physical Properties | Complies with ASTM
D5250-06 (reapproved
2011)
Before Aging/After Aging
Tensile Strength ≥11MPa
Ultimate Elongation ≥300% | Complies with ASTM
D5250-06 (reapproved
2011)
Before Aging/After Aging
Tensile Strength ≥11MPa
Ultimate Elongation ≥300% | Same |
| Freedom from Holes | Complies with ASTM
D5250-06 (reapproved
2011) and ASTM D5151-
06 (reapproved 2011)
G-1, AQL 2.5 | Complies with ASTM
D5250-06 (reapproved
2011) and ASTM D5151-
06 (reapproved 2011)
G-1, AQL 2.5 | Same |
| Powder or Powder-free | Powder-free | Powder-free | Same |
| Residual Powder | Complies with ASTM
D5250-06 (reapproved
2011)