Vinyl patient examination glove, Powder Free

K153159 · Xingyuan Plastic Products Co., Ltd. · LYZ · Jan 26, 2016 · General Hospital

Device Facts

• Record ID: K153159
• Device Name: Vinyl patient examination glove, Powder Free
• Applicant: Xingyuan Plastic Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Jan 26, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Vinyl patient examination glove, Powder Free, is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Device Story

Vinyl patient examination glove; disposable; non-sterile; ambidextrous; smooth surface. Worn by healthcare examiners to provide barrier protection against contamination between patient and examiner. Device is manufactured from vinyl; available in various sizes (S, M, L, XL). Bench testing confirms compliance with ASTM D5250 standards for physical properties, freedom from holes, and powder content. Biocompatibility verified per ISO 10993-10 for skin irritation and sensitization. No colorant used.

Clinical Evidence

Bench testing only. Testing included physical property evaluation (tensile strength, elongation), freedom from holes (ASTM D5151), residual powder content (ASTM D6124), and biocompatibility (ISO 10993-10 for irritation and sensitization). Results demonstrate compliance with ASTM D5250 standards.

Technological Characteristics

Material: Vinyl. Design: Ambidextrous, smooth, powder-free. Dimensions: Length 230mm, width 85-115mm, thickness ≥0.05mm (finger), 0.08mm (palm). Standards: ASTM D5250-06, ASTM D5151-06, ASTM D6124-06, ISO 2859-1, ISO 10993-10. Non-sterile.

Indications for Use

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

• BLUE VINYL GLOVES POWDER FREE (K150224)

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 stylized caduceus symbol, which features a staff with a snake winding around it, overlaid with three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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

January 26, 2016

Xingyuan Plastic Products Co., Ltd. % Mr. Ray Wang Official Correspondent Beijing Believe Tech. Service Co., Ltd. 1-202, Build 3, Beijing New World, No.5 Chaoyang Rd., Chaoyang District Beijing, 100024 CHINA

Re: K153159

Trade/Device Name: Vinyl Patient Examination Glove, Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: December 16, 2015 Received: December 18, 2015

Dear Mr. 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

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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. Division 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)

K153159

Device Name

Vinyl patient examination glove, Powder Free

Indications for Use (Describe)

The Vinyl patient examination glove, Powder Free, is a disposable device intended for medical purposes that is worn on the examiner's hands or finger 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) CONTINUE ON A SEPARATE PAGE IF NEEDED. 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 Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff

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PSC Publishing Services [phone]

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# Exhibit 2 510(k) Summary

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

The assigned 510(k) Number: K153159

- 1. Date of Preparation: 2016/01/26
- 2. Sponsor

XINGYUAN PLASTIC PRODUCTS CO.,LTD. #100,CHANGDA ROAD, SIGEZHUANG, LUANNAN COUNTY, TangShan City, Hebei PROV., 063503, CHINA Contact Person: Mr. Qiwei Xing Tel: [phone] Fax: [phone] Email: [e-mail]

- Submission Correspondent 3. Mr. Ray Wang Beijing Believe Tech. Service Co., Ltd. Tel: [phone] Fax: [phone] Email: [e-mail]
- Proposed Device Identification 4.

Trade Name: Vinyl patient examination glove, Powder Free Device Name: Vinyl Patient Examination Gloves (Powder Free) Common Name: Patient Examination Gloves

Classification: I Product Code: LYZ Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital

Intended Use Statement: The Vinyl patient examination glove, Powder Free, is a disposable device intended for medical

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purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

- 5. Predicate Device Identification
510(k) Number: k150224 Product Name: BLUE VINYL GLOVES POWDER FREE Manufacturer: ZIBO SANYING TRADE CO., LTD

- Device Description 6.
The proposed device, Vinyl patient examination glove, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

The proposed is Powder Free Vinyl Patient Examination Gloves without color, and includes variations of different size.

- 7. Non-Clinical Test Conclusion
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ASTM D5250-06, Standard Specification for Poly(vinyl chloride) Gloves for Medical Application. ASTM D 5151-06 (Reapproved 2011), Standard Test Method for Detection of Holes in Medical Gloves.

ASTM D6124-06 (Reaffirmation 2011), Standard Test Method for Residual Powder on Medical Gloves.

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.

ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

- 8. Substantially Equivalent Comparison Conclusion

| ITEM | Proposed Device | Predicated Device | Remark |
|----------------|-------------------------------------------------|------------------------------------------|--------|
| | Vinyl patient examination glove, Powder<br>Free | BLUE VINYL GLOVES POWDER FREE<br>K150224 | |
| Product Code | LYZ | LYZ | SE |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | SE |
| Class | I | I | SE |

Table 1 General Comparison

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| | The Vinyl patient examination glove,<br>Powder Free, is a disposable device<br>intended for medical purposes that is worn<br>on the examiner's hands or finger to<br>prevent contamination between patient and<br>examiner. | The BLUE VINYL GLOVES POWDER<br>FREE is a disposable device intended for<br>medical purposes that is worn on the<br>examiner's hands or finger to prevent<br>contamination between patient and<br>examiner. | |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|
| Intended Use | | | SE |
| Powdered or<br>Powered free | Powdered free | Powdered free | SE |
| Design Feature | ambidextrous, smooth | ambidextrous, smooth | SE |

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| | Designation | Size | | | | Tolerance |
|----------------------------------------------------------------|----------------|--------|-----|-----|-----|-----------|
| Proposed Device | Length, mm | S | M | L | XL | |
| Vinyl patient examination glove,<br>Powder Free | Length, mm | 230 | 230 | 230 | 230 | min |
| | Width, mm | 85 | 95 | 105 | 115 | ±5 |
| | Thickness, mm: | | | | | |
| | Finger | ≥ 0.05 | | | | min |
| | Palm | 0.08 | | | | min |
| | Designation | Size | | | | Tolerance |
| Predicate Device (k150224)<br>BLUE VINYL GLOVES<br>POWDER FREE | Length, mm | S | M | L | XL | |
| | Length, mm | 240 | 240 | 240 | 240 | min |
| | Width, mm | 85 | 95 | 105 | 115 | ±5 |
| | Thickness, mm: | | | | | |
| | Finger | 0.10 | | | | min |
| | Palm | 0.08 | | | | min |
| Remark | Analysis 1 | | | | | |

Table 2 Device Dimensions Comparison

## Analysis 1:

Although the proposed device has different with the predicated device in thickness of finger and palm, but the specifications of proposed device meet the requirements of ASTM D5250.

So we consider this as the proposed device is SE with the predicate device.

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| ITEM | | | Proposed Device<br>Vinyl patient examination glove,<br>Powder Free | Predicated Device<br>BLUE VINYL GLOVES<br>POWDER FREE<br>K150224 | Remark |
|------------------------|-----------------|------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|------------|
| Colorant | | | N/A | Blue | Analysis 2 |
| Physical<br>Properties | Before<br>Aging | Tensile<br>Strength | 11 MPa, min | 13 MPa, min | Analysis 3 |
| | | Ultimate<br>Elongation | 300 % min | 400 % min | |
| | After<br>Aging | Tensile<br>Strength | 11 MPa, min | 13 MPa, min | |
| | | Ultimate<br>Elongation | 300 % min | 400 % min | |
| | | | Comply with ASTM D5250 | Comply with ASTM D5250 | SE |
| Freedom from Holes | | | Be free from holes when tested in<br>accordance with ASTM D5151 | Be free from holes when tested<br>in accordance with ASTM<br>D5151 | SE |
| Powder Content | | | 0.50 mg per glove | Meet the requirements of ASTM<br>5250 | SE |

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

### Analysis 2:

The proposed device has no color rather than blue of the predicate device, this different may causes potential biocompatibility, for this risk we conducted the biocompatibility test according to the ISO 10993-10, the test results showed that the proposed devices did not induce skin irritation and showed no significant evidence of causing skin sensitization.

So we consider this as the proposed device is SE with the predicate device.

### Analysis 3:

Although the proposed device has different with the predicated device in physical properties, but the specifications of proposed device meet the requirements of ASTM D5250.

So we consider this as the proposed device is SE with the predicate device.

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| ITEM | Proposed Device | Predicated Device | Remark | |
|--------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------|----|
| | Vinyl patient examination glove,<br>Powder Free | BLUE VINYL GLOVES POWDER<br>FREE<br>K150224 | | |
| Material | Vinyl | Vinyl | SE | |
| Biocompatibility | Irritation | Under the conditions of the study,<br>not an irritant | Comply with ISO 10993-10 | SE |
| | Sensitization | Under conditions of the study, not a<br>sensitizer. | | SE |
| Label and Labeling | Single-use indication, powder free,<br>device name, glove size and quantity,<br>Vinyl Examination Gloves,<br>Non-Sterile | Single-use indication, powder free,<br>device name, glove size and quantity,<br>Vinyl Examination Gloves,<br>Non-Sterile | SE | |

Table 4 Safety Comparison

Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.