Vinyl Patient Examination Glove (Yellow)

K173561 · Yurun Glove Co., Ltd. · LYZ · Feb 12, 2018 · General Hospital

Device Facts

• Record ID: K173561
• Device Name: Vinyl Patient Examination Glove (Yellow)
• Applicant: Yurun Glove Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Feb 12, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Vinyl Patient Examination Glove (Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

Device Story

Vinyl Patient Examination Glove (Yellow) is a non-sterile, powder-free, ambidextrous disposable glove. Used by healthcare examiners to provide a barrier against contamination between patient and examiner. Manufactured from vinyl material. Device is available in sizes S, M, L, and XL. Performance verified against ASTM D5250, ASTM D5151, and ASTM D6124 standards. Device is intended for single-use.

Clinical Evidence

No clinical data. Bench testing only. Compliance with ISO 10993-10 (irritation/sensitization), ISO 10993-5 (cytotoxicity), ASTM D6124 (residual powder), ASTM D5151 (freedom from holes), and ASTM D5250 (physical properties) demonstrated.

Technological Characteristics

Material: Vinyl. Form factor: Ambidextrous, non-sterile, powder-free. Dimensions: Length 230mm, width 85-115mm (size dependent). Standards: ASTM D5250, ASTM D5151, ASTM D6124, ISO 10993-5, ISO 10993-10, ISO 2859-1.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hands to prevent contamination between patient and examiner. Suitable for use by healthcare professionals or in over-the-counter settings.

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 (White, Blue or Yellow) (K163168)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is blue.

February 12, 2018

Yurun Glove Co., Ltd. % Ray Wang Official Correspondent Beijing Believe-Med Technology Service Co., Ltd. 5-402, Building #27, No. 56, LiangXiang East Rd., FangShan District Beijing, 102401 Cn

Re: K173561

Trade/Device Name: Vinyl Patient Examination Glove (Yellow) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: November 15, 2017 Received: November 17, 2017

Dear Ray Wang:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements 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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting 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)

#### K173561

Device Name Vinyl Patient Examination Glove (Yellow)

Indications for Use (Describe)

The Vinyl Patient Examination Glove (Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands 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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# 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K173561

- 1. Date of Preparation:2018/01/26
- 2. Sponsor Identification

# YURUN GLOVE CO., LTD. No.10 ZHAOCAI STREET, LUANNAN COUNTY, SHITANGSHAN CITY, HEBEI,CHINA

Contact Person: Chao kevin Position: General Manager Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Mr. Ray Wang

#### Beijing Believe-Med Technology Service Co., Ltd.

Tel: [phone], Fax: [phone] Email: [e-mail]

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- 4. Identification of Proposed Device
Trade Name: Vinyl Patient Examination Glove (Yellow) Common Name: Vinyl Patient Examination Gloves (Powder Free) Model(s): S M L XL

Regulatory Information Classification Name: Vinyl Patient Examination Gloves (Powder Free) Classification: I Product Code: LYZ Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital

Indication for use Statement:

The Vinyl Patient Examination Glove (Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

- 5. Device Description
The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is yellow. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile.

- 6. Identification of Predicate Device(s)
Predicate Device K163168 Vinyl Examination Gloves (White, Blue or Yellow) Hebei Hongtai Plastic Products Company Limited

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| ITEM | Proposed Device (K173561) | Predicate Device (K163168) | Remark |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | LYZ | LYZ | SAME |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | SAME |
| Class | I | I | SAME |
| Intended Use | The Vinyl Patient Examination Glove<br>(Yellow) is a disposable device intended<br>for medical purposes that is worn on the<br>examiner's hands to prevent contamination<br>between patient and examiner. | The Vinyl Examination Glove (White,<br>Blue, or Yellow) is a disposable device<br>intended for medical purposes that is worn<br>on the examiner's hands to prevent<br>contamination between patient and<br>examiner. | SAME |
| Powdered or<br>Powered free | Powdered free | Powdered free | SAME |
| Design Feature | ambidextrous | ambidextrous | SAME |
| Labeling<br>Information | Single-use indication, powder free, device<br>color, device name, glove size and quantity,<br>Vinyl Examination Gloves, Non-Sterile | Single-use indication, powder free, device<br>color, device name, glove size and quantity,<br>Vinyl Examination Gloves, Non-Sterile | SAME |

#### Technological Comparison Table 7.

Table 1 General Comparison

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| | | Size | | | | | |
|----------------------------|----------------|------------|-----|-----|-----|-----------|-----------|
| | Designation | XS | S | M | L | XL | Tolerance |
| | Length, mm | 230 | 230 | 235 | 245 | 245 | min |
| Predicate Device (K163168) | Width, mm | 80 | 85 | 95 | 105 | 115 | ±5 |
| | Thickness, mm: | | | | | | |
| | Finger | 0.05 | | | | | min |
| | Palm | 0.08 | | | | | min |
| | | Size | | | | | |
| | Designation | S | M | L | XL | Tolerance | |
| | Length, mm | 230 | 230 | 230 | 230 | min | |
| Proposed Device (K173561) | Width, mm | 85 | 95 | 105 | 115 | ±5 | |
| | Thickness, mm: | | | | | | |
| | Finger | 0.05 | | | | | min |
| | Palm | 0.08 | | | | | min |
| Remark | | Analysis 1 | | | | | |

Table 2 Device Dimensions Comparison

### Analysis 1:

The proposed device has different size specification to the predicate device, but all proposed device meets the specifications of ASTM D 5250.

| | Table 3 Performance Comparison | |
|--|--------------------------------|--|
| | | |

| ITEM | Proposed Device (K173561) | Predicate Device (K163168) | Remark | |
|------------------------|---------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------|------------|
| Colorant | Yellow | White, Blue, Yellow | SAME | |
| Physical<br>Properties | Before<br>Aging<br>Tensile<br>Strength | 12 MPa, min | 15 MPa, min | Analysis 2 |
| | Before<br>Aging<br>Ultimate<br>Elongation | 300 % min | 380 % min | |
| | After<br>Aging<br>Tensile<br>Strength | 12 MPa, min | 15 MPa, min | |
| | After<br>Aging<br>Ultimate<br>Elongation | 300 % min | 380 % min | |
| Freedom from Holes | Be free from holes when tested in<br>accordance with ASTM D5151<br>Level=G-I, AQL=1.5 | Be free from holes when tested<br>in accordance with ASTM<br>D5151<br>AQL=1.5 | SAME | |
| Powder Content | 1.7 mg | Meet the requirements of ASTM<br>5250 | SAME | |

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| ITEM | Proposed Device (K173561) | Predicate Device (K163168) | Remark |
|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|------------------------------------------|--------|
| Material | Vinyl | Vinyl | SAME |
| Biocompatibility | | | SAME |
| | Irritation<br>Under the conditions of the study, not an irritant | Comply with ISO 10993-10 | |
| | Sensitization<br>Under conditions of the study, not a sensitizer. | N/A | |
| Cytotoxicity<br>Under conditions of the study, did not show potential toxicity to L-929 cells. | | | |
| Label and Labeling | Meet FDA's Requirements of 21<br>CFR 801 | Meet FDA's Requirements of 21<br>CFR 801 | SAME |

| | | Table 4 Safety Comparison |
|--|--|---------------------------|
| | | |

#### Analysis 2:

The proposed device has different Ultimate Elongation after aging specification to the predicate device, but all proposed device meets the specification requirements of ASTM D 5250.

#### 8. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all specifications. The test results demonstrated that the proposed device complies with the following standards:

- > ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- > ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- > ASTM D6124-06 (Reaffirmation 2011), Standard Test Method for Residual Powder on Medical Gloves
- > ASTM D 5151-06 (Reapproved 2015), Standard Test Method for Detection of Holes in Medical Gloves.
- > ASTM D5250-06 (Reapproved 2015), Standard Specification for Poly(vinyl chloride) Gloves for Medical Application.
- > ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.
- 9. Clinical Test Conclusion

No clinical study is included in this submission.

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### 10. Comparison Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.