Glide-On Vinyl Examination Gloves

K151754 · Medline Industries, Inc. · LYZ · Mar 22, 2016 · General Hospital

Device Facts

• Record ID: K151754
• Device Name: Glide-On Vinyl Examination Gloves
• Applicant: Medline Industries, Inc.
• Product Code: LYZ · General Hospital
• Decision Date: Mar 22, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

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.

Device Story

Disposable, non-sterile, powder-free vinyl (PVC) examination gloves; inner polyurethane coating acts as lubricant to facilitate donning on wet, damp, or dry hands. Used in clinical settings by healthcare professionals to prevent cross-contamination between patient and examiner. Device provides physical barrier protection. Performance validated via bench testing for biocompatibility, physical properties, and frictional characteristics; user study evaluated donning ease and durability compared to similar polyurethane-coated vinyl gloves.

Clinical Evidence

No clinical testing was performed. Evidence consists of bench testing for biocompatibility (ISO 10993-10: irritation and sensitization), physical properties (ASTM D5250-06), and frictional properties (ASTM D1894). A user study (n=170) evaluated donning time and glove integrity on damp/dry hands compared to other polyurethane-coated vinyl gloves.

Technological Characteristics

Material: Polyvinyl chloride (PVC) with inner polyurethane coating (viscosity up to 18 centipoise). Dimensions and physical properties comply with ASTM D5250-06. Freedom from holes tested per ASTM D5151-06. Non-sterile. Single-use. No colorant used.

Indications for Use

Indicated for use by medical examiners to prevent cross-contamination between patient and examiner during medical procedures.

Regulatory Classification

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.

Predicate Devices

• Powder-Free PVC Vinyl Patient Examination Glove, Clear (non-colored) (K142703)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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: [phone] Email: [e-mail]

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

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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<br>Analysis |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Glide-On Vinyl<br>Examination Gloves | Powder-free PVC Vinyl<br>Exam Gloves | N/A |
| 510(k) Reference | | K142703 | N/A |
| Product Owner | Medline Industries, Inc | Hebei Grandeast Plastic<br>Products Co., Ltd. | Different |
| Product Code | LYZ | LYZ | Same |
| Intended Use | The Glide-On Vinyl<br>Examination Gloves are<br>disposable device intended<br>for medical purposes that<br>are worn on the examiner's<br>hands or fingers to prevent<br>contamination between<br>patient and examiner. | The powder-free PVC vinyl<br>exam gloves are disposable<br>devices intended for<br>medical purposes that are<br>worn on the examiner's<br>hands or fingers to prevent<br>contamination between<br>patient and examiner. | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Sizes | Small<br>Medium<br>Large<br>Extra-Large | Small<br>Medium<br>Large<br>Extra-Large | Same |
| Materials | PVC<br>Lubricant - Polyurethane<br>with a viscosity up to 18<br>centipoise | PVC<br>Lubricant - Polyurethane<br>with a viscosity up to 4.6<br>centipoise | Similar |
| Dimensions - Length | Complies with ASTM<br>D5250-06 (reapproved) | Complies with ASTM<br>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<br>D5250-06 (reapproved<br>2011)<br>Small - 85±5mm<br>Medium - 95±5mm<br>Large - 105±5mm<br>Extra Large - 115±5mm | Complies with ASTM<br>D5250-06 (reapproved<br>2011)<br>Small - 85±5mm<br>Medium - 95±5mm<br>Large - 105±5mm<br>Extra Large - 115±5mm | Same |
| Dimensions - Thickness | Complies with ASTM<br>D5250-06 (reapproved<br>2011)<br>Palm - 0.10±0.02mm<br>Finger - 0.10±0.02mm | Complies with ASTM<br>D5250-06 (reapproved<br>2011)<br>Palm - 0.10±0.02mm<br>Finger - 0.10±0.02mm | Same |
| Physical Properties | Complies with ASTM<br>D5250-06 (reapproved<br>2011)<br>Before Aging/After Aging<br>Tensile Strength ≥11MPa<br>Ultimate Elongation ≥300% | Complies with ASTM<br>D5250-06 (reapproved<br>2011)<br>Before Aging/After Aging<br>Tensile Strength ≥11MPa<br>Ultimate Elongation ≥300% | Same |
| Freedom from Holes | Complies with ASTM<br>D5250-06 (reapproved<br>2011) and ASTM D5151-<br>06 (reapproved 2011)<br>G-1, AQL 2.5 | Complies with ASTM<br>D5250-06 (reapproved<br>2011) and ASTM D5151-<br>06 (reapproved 2011)<br>G-1, AQL 2.5 | Same |
| Powder or Powder-free | Powder-free | Powder-free | Same |
| Residual Powder | Complies with ASTM<br>D5250-06 (reapproved<br>2011)<br><2mg per glove | Complies with ASTM<br>D5250-06 (reapproved<br>2011)<br><2mg per glove | Same |
| Colorant | No colorant used | No colorant used | Same |
| Sterile or Non-sterile | Non-sterile | Non-sterile | Same |

# Summary of Non-Clinical Testing

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:

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Image /page/6/Picture/0 description: The image shows the Medline logo. The logo is set against a blue square background. The word "MEDLINE" is written in white, with a stylized white symbol resembling a star or a stylized cross above the text. A gray bar is visible on the right side of the blue square.

ledline Industries. Inc One Medline Place Mundelein, IL 60060

- 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.

## Summary of Clinical Testing

This section does not apply. No clinical testing was performed.

#### Conclusion

Based on the non-clinical performance testing Medline Industries, Inc. concludes that the Glide-On Vinyl Examination Gloves are substantially equivalent to the predicate, Powder-free PVC Vinyl Exam Gloves (K142703).