Powder-free Clear Vinyl Patient Examination Gloves

K142892 · Shenyi (Shandong) Plastic Products Co., Ltd. · LYZ · Mar 25, 2015 · General Hospital

Device Facts

• Record ID: K142892
• Device Name: Powder-free Clear Vinyl Patient Examination Gloves
• Applicant: Shenyi (Shandong) Plastic Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Mar 25, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.

Device Story

Disposable, non-sterile, ambidextrous patient examination glove made of poly vinyl chloride. Worn by healthcare examiners on hands or fingers to provide a physical barrier against contamination between patient and examiner. Used in clinical settings. Device functions as a passive barrier; no active components, software, or algorithms. Performance verified through physical property, barrier, and biocompatibility testing.

Clinical Evidence

No clinical data. Bench testing only. Testing included physical dimensions, tensile strength, elongation (ASTM D5250-06), barrier properties/pinhole testing (ASTM D5151-06), residual powder (ASTM D6124-06), and biocompatibility (ISO 10993-10 for skin irritation and sensitization).

Technological Characteristics

Material: Poly Vinyl Chloride. Form factor: Ambidextrous, disposable, non-sterile glove. Standards: ASTM D5250-06 (physical/performance), ASTM D5151-06 (barrier), ASTM D6124-06 (residual powder), ISO 10993-10 (biocompatibility). No energy source, software, or connectivity.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hands or fingers to prevent cross-contamination between patient and examiner.

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

• Vinyl Examination Gloves, Powder-Free (K022091)

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 25, 2015

Shenyi Shandong Plastic Products, Co. Ltd. C/O Mr. Ray Zhou Official Correspondent Basic Medical Industries, Inc. 12390 East End Ave. Chino, CA 91710

Re: K142892

Trade/Device Name: Powder-Free Clear Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: February 13, 2015 Received: February 23, 2015

Dear Mr. Zhou:

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.

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Page 2 - Mr. Zhou

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 I. 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

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#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K142892

Device Name

Powder-free Clear Vinyl Patient Examination Gloves

Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purposes that is worn upon 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)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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## 510(k) Summary

#### Submitter's Name and Address:

Shenyi (Shandong) Plastic Products, Co. Ltd. No.23 Fenghuang Road Fengshan Industry Park Linzi Shandong, 255400 China

#### Contact Person:

Minghao Shi, Marketing Manager Phone: # [phone]

#### Date Summary prepared: March 19, 2015

#### Name of the Device:

Powder-free Clear Vinyl Patient Examination Gloves

#### Assigned 510(k) Number

K142892

#### Common name/classification name of the Device:

Patient Examination Glove Device Class: Class I Regulation number: 21 CFR 880.6250 Product code: LYZ

#### Predicate Device Information:

Device name: Vinyl Examination Gloves, Powder-Free 510(K) #: K022091 Manufacturer name: Tangshan Zhonghong Pulin Food Products Co., Ltd

#### Device Description:

The subject device is Powder-Free Vinyl Patient Examination Gloves that is worn upon the examiner's hands or finger. As a barrier, the subject device prevents contamination between patient and examiner. The subject device meets all of the requirements of ASTM standards D5250-06 for Physical and performance characteristics, D5151-06 for barrier properties and D6124-06 for residual powder.

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## Indications for Use:

The subject device is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner.

## Comparison to Predicate Devices:

Powder-free Clear Vinyl Patient Examination Gloves (K142892) is substantially equivalent to the Vinyl Examination Gloves, Powder-Free (K022091).

| | Proposed Device (K142892) | Predicate Device (K022091) | COMMENTS |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| The device | Shenyi (Shandong) Plastic<br>Products, Co. Ltd. Powder-<br>free Clear Vinyl Patient<br>Examination Gloves | Vinyl Examination Gloves,<br>Powder-Free Tangshan<br>Zhonghong Pulin Food<br>Products Co., Ltd | |
| Regulation # | 21 CFR 880.6250 | 21 CFR 880.6250 | Substantially<br>equivalent |
| Device Class | Class I | Class I | Substantially<br>equivalent |
| Product Code: | LYZ | LYZ | Substantially<br>equivalent |
| Indications for<br>Use | Disposable device intended for<br>medical purposes that is worn<br>on the examiner's hand or<br>finger to prevent<br>contamination between patient<br>and examiner | Disposable device intended<br>for medical purposes that is<br>worn on the examiner's hand<br>or finger to prevent<br>contamination between<br>patient and examiner | Substantially<br>equivalent |
| Basic Design | Cover the hand and wrist area.<br>Clovers have separate sheaths<br>or openings for each finger<br>and the thumb. | Cover the hand and wrist<br>area. Clovers have separate<br>sheaths or openings for each<br>finger and the thumb. | Substantially<br>equivalent |
| Device Materials | Poly Vinyl Chloride | Poly Vinyl Chloride | Substantially<br>equivalent |
| Residual Powder | <2 mg per glove<br>Conform to ASTM D6124-06. | < 2 mg per glove<br>Conform to ASTM D6124 | Substantially<br>equivalent |
| Length on Large<br>Size | Conform to ASTM D5250,<br>2011 | Conform to ASTM D5250<br>2002 | Substantially<br>equivalent |
| Width of Palm on<br>Large Size | Conform to ASTM D5250,<br>2011 | Conform to ASTM D5250<br>2002 | Substantially<br>equivalent |
| Palm Thickness | Conform to ASTM D5250,<br>2011 | Conform to ASTM D5250<br>2002 | Substantially<br>equivalent |
| Fingertip<br>Thickness | Conform to ASTM D5250,<br>2011 | Conform to ASTM D5250<br>2002 | Substantially<br>equivalent |

## Substantial Equivalence Comparison Table

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| Before & After<br>Aging: Tensile<br>Strength(Mpa)<br>and Ultimate<br>Elongations | ≥11MPa (Tensile strength)<br>≥360% (elongation)<br>Conform to ASTM D5250-06 | ≥11MPa (Tensile strength)<br>≥360% (elongation)<br>Conform to ASTM D5250 | Substantially<br>equivalent |
|----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Pinhole Results | AQL 2.5<br>Conform to ASTM D5151-06 | AQL 2.5<br>Conform to ASTM D5151 | Substantially<br>equivalent |
| Primary Skin<br>Irritation<br>Per ISO-10993-10 | Not an irritant under the<br>condition of study | Not an irritant under the<br>condition of study | Substantially<br>equivalent |
| Dermal<br>Sensitization<br>Per ISO-10993-10 | Not a sensitizer under the<br>condition of study | Not a sensitizer under the<br>condition of study | Substantially<br>equivalent |
| Labeling | Labels include: Product name;<br>Non-sterile; color; "single use<br>Only" size, Quantity,<br>ambidextrous, lot number,<br>distributor name, indication<br>for use and manufacturer<br>address. | Labels include: Product<br>name; Non-sterile; color;<br>"single use" size, Quantity,<br>ambidextrous, distributor<br>name, indication for use and<br>manufacturer address. | Substantially<br>equivalent |
| Substantial<br>equivalence | The subject device in K142892, Powder-free Clear Vinyl Patient Examination<br>Gloves, has similar indications for use, design, material, physical and barrier<br>properties and Biocompatibility and is substantially equivalent to the predicate<br>device (K022091). | | |

### Discussion of Non-Clinical tests performed for Determination of Substantial Equivalence are as follows:

Non-clinical tests were conducted on the subject device.

The dimensions and physical properties tests followed ASTM D5250-06 and met AQL 2.5, inspection level S-2.

The barrier test followed ASTM D5151-06 and met AQL 2.5, inspection level S-1. Residual powder test followed ASTM D6124 and met the requirement of powder-free glove.

Biocompatibility test followed ISO 10993-10 showing no primary skin irritation or sensitization, under the conditions of study.

The subject device met the requirements of non-clinical tests, and performed similar to the predicate device.

### Sterilization

The subject device is non-sterile examination gloves for single use.

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## Discussion of Clinical Tests Performed:

Not Applicable

## Conclusions:

Powder-free Vinyl Patient Examination Glove, the subject device in K142892, has similar Indications for Use and technological characteristics, and is substantially equivalent to the predicate device (K022091).