Cream Stretch Vinyl Patient Examination Glove (Non-Sterile),White Vinyl Patient Examination Glove (Non-Sterile),

K143277 · Lifestyle Safety Products (Hui Zhou) Co., Ltd. · LYZ · Jul 29, 2015 · General Hospital

Device Facts

• Record ID: K143277
• Device Name: Cream Stretch Vinyl Patient Examination Glove (Non-Sterile),White Vinyl Patient Examination Glove (Non-Sterile),
• Applicant: Lifestyle Safety Products (Hui Zhou) Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Jul 29, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Cream Stretch Vinyl Patient Examination Glove (Non-Sterile) and White Vinyl Patient Examination Glove (Non-Sterile) are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. They are both sold as non-sterile.

Device Story

Disposable patient examination gloves; made of poly vinyl chloride; available in sizes S, M, L, XL. Used by healthcare examiners to prevent cross-contamination between patient and examiner. Provided non-sterile. Performance meets ASTM D5250-06 standards for physical properties and dimensions. Biocompatibility testing confirms non-irritant and non-sensitizing properties.

Clinical Evidence

Bench testing only. Performance data includes physical properties (tensile strength, elongation), freedom from pinholes (ASTM D5151-06), and powder residue (ASTM D6124-06). Biocompatibility testing conducted per ISO 10993-1 and G95-1, including cytotoxicity, sensitization, and primary dermal irritation studies, all of which passed.

Technological Characteristics

Material: Poly Vinyl Chloride. Form factor: Disposable examination glove, sizes S-XL. Standards: ASTM D5250-06 (physical properties/dimensions), ASTM D5151-06 (pinholes), ASTM D6124-06 (powder residue). Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization). Non-sterile.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent 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

• Powder-Free Non-Sterile Vinyl Examination Glove (K100978)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 29, 2015

Lifestyle Safety Products (Hui Zhou) Co., Ltd. c/o Ms. Rhonda Alexander, M.S. M.P.A Senior Regulatory Specialist Registrar Corp 144 Research Drive Hampton, VA 23666

Re: K143277

Trade/Device Name: Cream Stretch Vinyl Patient Examination Glove (Non-Sterile), White Vinvl Patient Examination Glove (Non-Sterile) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: June 3, 2015 Received: June 4, 2015

Dear Ms. Alexander:

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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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 devicerelated 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 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 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

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K143277

#### Device Name

Device Name

#### Indications for Use (Describe)

The Cream Stretch Vinyl Patient Examination Glove (Non-Sterile) and White Vinyl Patient Examination Glove (Non-Sterile) are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. They are both sold as non-sterile.

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)

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

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# 510(k) Summary (21 CFR 807.92)

#### l. SUBMITTER

Lifestyle Safety Products (Hui Zhou) Co., Ltd Daxiaotang Village, Luoyang Town, Boluo County Hui Zhou City, Guang Dong Province, 516120 China

0086-0752-6863042 (phone) 0086-0752-6863392 (fax) Name of contact person: Mr. Lee Hong Chong Date the summary was prepared: September 9, 2014

### II. DEVICE

Name of Device: Classification Name: Regulatory Class: Product Code:

Cream Stretch Vinyl Patient Examination Glove(Non-Sterile) White Vinyl Patient Examination Glove (Non-Sterile) Patient Examination Glove । LYZ

## III. PREDICATE DEVICE

K100978: Powder-Free Non-Sterile Vinyl Examination Glove Manufactured by Jiangsu Sunshine Plastic Products, Co., Ltd

This predicate has not been subject to a design-related recall.

No reference devices were used in this submission.

## IV. DEVICE DESCRIPTION

Cream Stretch Vinyl Patient Examination Glove (Non-Sterile) and White Vinyl Patient Examination Glove (Non-Sterile) are patient examination gloves available in S, M, L, XL. They are provided non-sterile and meet the entire requirement of ASTM standard D 5250-06, except for sterility requirements.

#### V. INDICATIONS FOR USE

The Cream Stretch Vinyl Patient Examination Glove (Non-Sterile) and White Vinyl Patient Examination Glove (Non-Sterile) are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. They are both sold as nonsterile.

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# VI. SUMMARY OF COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

| Description | White Vinyl Patient<br>Examination Glove (Non-<br>Sterile) | Cream Stretch Vinyl<br>Patient Examination<br>Glove (Non-Sterile) | Predicate Device K100978 |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Disposable device<br>intended for medical<br>purposes that is worn on<br>the examiner's hand or<br>finger to prevent<br>contamination between<br>patient and examiner | Disposable device<br>intended for medical<br>purposes that is worn on<br>the examiner's hand or<br>finger to prevent<br>contamination between<br>patient and examiner | The patient examination<br>glove is a disposable<br>device intended for<br>medical purposes that is<br>worn<br>on the examiner's hand or<br>finger to prevent<br>contamination between<br>patient and examiner. |
| Material | Poly Vinyl Chloride | Poly Vinyl Chloride | Poly Vinyl Chloride |
| Sizes | S, M, L, XL | S, M, L, XL | Information Unavailable |
| Single Use | Yes | Yes | Yes |
| Sterility | Non-sterile | Non-sterile | Non-sterile |

At a high level, the subject and predicate devices are based on the following same technological elements:

There are no significant technological differences between the subject and predicate devices:

| Characteristics | Cream Vinyl Patient<br>Examination Glove (Non-<br>Sterile) | White Vinyl Patient<br>Examination Glove<br>(Non-Sterile) | Predicate Device<br>performance |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Dimension | Length 246mm<br>Width:<br>S size = 85mm<br>M size = 95mm<br>L size = 105mm<br>XL size = 115mm<br>Finger thickness = 0.05mm<br>Palm thickness = 0.08mm<br>Meets ASTM D 5250-06 | Length: 243mm Width:<br>S size = 85mm<br>M size = 95mm<br>L size = 105mm<br>XL size = 115mm<br>Finger thickness =<br>0.05mm Palm thickness<br>= 0.08mm<br>Meets ASTM D5250-06 | Meets ASTM D 5250-06 |
| Physical Properties | Tensile strength = 16.3MPa<br>Elongation = 391%<br>Meets ASTM D 5250-06 | Tensile strength =<br>15.7MPa<br>Elongation = 385%<br>Meets ASTM D 5250-06 | Meets ASTM D 5250-06 |
| Freedom from pinholes | Pinhole = 8/500<br>AQL 1.5<br>Meets ASTM D5151-06 | Pinhole = 10/500<br>AQL 1.5<br>Meets ASTM D5151-06 | Meets 21 CFR 800.20 |
| Powder Residual | Powder residue = 1mg<br>Meets ASTM D5250-06 and<br>D6124-06 | Powder residue = 1mg<br>Meets ASTM D5250-06<br>and D6124-06 | Meets ASTM D6124-06 |
| Cytotoxicity<br>(ISO10993-5) | Passes | Passes | N/A |
| Biocompatibility | Primary Dermal Irritation<br>in rabbits - under the | Primary Dermal<br>Irritation in rabbits - | Passes |

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| conditions of the study, not<br>an irritant. | under the conditions of<br>the study, not an<br>irritant. | |
|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|--------|
| Dermal Sensitization in the<br>guinea pig – under<br>conditions of the study;<br>not a sensitizer. | Dermal Sensitization in<br>the guinea pig – under<br>conditions of the study;<br>not a sensitizer. | Passes |

## VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

- ASTM D5250-06 o
- . ASTM D5151

## Biocompatibility testing

The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

- . Cytotoxicity
- . Sensitization
- Irritation .

The subject device is considered to be a surface device, contacting intact skin, for a duration of less than 24 hours.

#### VIII. CONCLUSIONS

Since there are minimal differences between the predicate device and the subject devices, we conclude that the subject devices perform comparably to the predicate device that is currently marketed for the same intended use.