Vinyl Examination Glove (Clear, Non-Colored)

K180861 · Zhicheng Trading Co., Ltd. · LYZ · Jun 13, 2018 · General Hospital

Device Facts

• Record ID: K180861
• Device Name: Vinyl Examination Glove (Clear, Non-Colored)
• Applicant: Zhicheng Trading Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Jun 13, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Vinyl Examination Glove (Clear, Non-Colored) 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 examination glove; disposable; non-sterile; ambidextrous; powder-free. Used by healthcare personnel to provide a physical barrier against contamination between patient and examiner. Device functions as a protective barrier; material properties (tensile strength, elongation, freedom from holes) verified via bench testing. No clinical data or software components.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility (cytotoxicity, irritation, sensitization) and physical property testing (tensile strength, elongation, freedom from holes, powder content) per ASTM and ISO standards.

Technological Characteristics

Material: Vinyl (polyvinyl chloride). Design: Ambidextrous, powder-free, clear/non-colored. Standards: ASTM D6124 (residual powder), ASTM D5151 (holes), ASTM D5250 (specifications), ISO 10993-5/10 (biocompatibility), ISO 2859-1 (sampling). Non-sterile.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hands 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

• Vinyl Patient Examination Gloves (White, Blue, Yellow) (K163168)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 13, 2018

Zhicheng Trading Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd. FangShan District Beijing, 102401 Cn

Re: K180861

Trade/Device Name: Vinyl Examination Glove (Clear, Non-Colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: March 30. 2018 Received: April 2, 2018

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device 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.

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 comprehensive regulatory information about medical devices and radiation-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,

Elizabeth F. Claverie -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)

K180861

Device Name Vinyl Examination Glove (Clear, Non-Colored)

Indications for Use (Describe)

The Vinyl Examination Glove (Clear, Non-Colored) 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 is being submitted in accordance with requirements in 21 CFR 807.92.

The assigned 510(k) Number: K180861

- 1. Date of Preparation:2018/05/14
- 2. Sponsor Identification

# ZHICHENG TRADING CO., LTD.

NORTH, BEIJING ROAD, ZHANGDIAN DISTRICT, ZIBO CITY, CHINA 255000 Establishment Registration Number: Not yet registered

Contact Person: Chong Zhao Position:Sales 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 Examination Glove (Clear, Non-Colored) 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 Examination Glove (Clear, Non-Colored) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

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

#### Identification of Predicate Device(s) 6.

Predicate Device K163168 Vinyl Patient Examination Gloves (White, Blue, Yellow) Hebei Hongtai Plastic Products Company Limited

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| ITEM | Proposed Device | 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>(Clear, Non-Colored) is a disposable<br>device intended for medical purposes that<br>is worn on the examiner's hands to prevent<br>contamination between patient and<br>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. | Similiar |
| 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 7.

Table 1 General Comparison

Table 2 Device Dimensions Comparison

| | | 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 | $\pm 5$ |
| | Thickness, mm: | | | | | | |
| | Finger | 0.05 | | | | | min |
| | Palm | 0.08 | | | | | min |
| | | Size | | | | | |
| | Designation | S | M | L | XL | | Tolerance |
| | Length, mm | 230 | 235 | 245 | 245 | | min |
| Proposed Device | Width, mm | 85 | 95 | 105 | 115 | | $\pm 5$ |
| | Thickness, mm: | | | | | | |
| | Finger | 0.05 | | | | | min |
| | Palm | 0.08 | | | | | min |
| Remark | SAME | | | | | | |

# Table 3 Performance Comparison

| ITEM | | | Proposed Device | Predicate Device (K163168) | Remark |
|------------------------|-----------------|---------------------|--------------------|----------------------------|------------|
| Colorant | | | Clear, Non-Colored | White, Blue, Yellow | Analysis 1 |
| Physical<br>Properties | Before<br>Aging | Tensile<br>Strength | 15 MPa, min | 15 MPa, min | SAME |

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| | | Ultimate<br>Elongation | 380 % min | 380 % min | |
|--------------------|----------------|------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|---------|
| | | Tensile<br>Strength | 15 MPa, min | 15 MPa, min | |
| | After<br>Aging | Ultimate<br>Elongation | 380 % min | 380 % min | |
| | | | Comply with ASTM D5250 | Comply with ASTM D5250 | SAME |
| Freedom from Holes | | | Be free from holes when tested in<br>accordance with ASTM D5151<br>AQL=1.5 | Be free from holes when tested<br>in accordance with ASTM<br>D5151 AQL=1.5 | SAME |
| | | | | | |
| Powder Content | | | 0.4 mg | Meet the requirements of ASTM 5250 | Similar |

### Table 4 Safety Comparison

| ITEM | Proposed Device | Predicate Device (K163168) | Remark | |
|--------------------|-----------------|----------------------------------------------------------------------------------------------------------------|--------------------------|---------|
| Material | Vinyl | Vinyl | SAME | |
| Biocompatibility | Irritation | Under the conditions of the study,<br>not an irritant | Comply with ISO 10993-10 | Similar |
| | Sensitization | Under conditions of the study, not a<br>sensitizer. | | |
| | Cytotoxicity | Under conditions of the study, did<br>not show potential toxicity to L-929<br>cells. Complies with ISO 10993-5 | / | |
| Label and Labeling | | Meet FDA's Requirements | Meet FDA's Requirements | SAME |

## Analysis 1:

The proposed device has different color to the predicate device, but all proposed devices are conducted the biocompatibility test, the test results shown difference do not effect the safety of proposed device.

#### 8. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications or acceptance criteria of the standards. The test results demonstrated that the proposed device met the design or acceptance criteria of 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

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- > ASTM D6124-06 (Reaffirmation 2011), Standard Test Method for Residual Powder on Medical Gloves
- > ASTM D5151-06 (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.
- Clinical Test Conclusion 9.

No clinical study is included in this submission.

- 10. 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.