Vinyl Co-Polymer Powder Free Examination Gloves

K142409 · Grand Work Plastic Products Co., Ltd. · LYZ · Dec 5, 2014 · General Hospital

Device Facts

• Record ID: K142409
• Device Name: Vinyl Co-Polymer Powder Free Examination Gloves
• Applicant: Grand Work Plastic Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Dec 5, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Vinyl Co-Polymer Powder-free Examination Gloves are disposable, non-sterile, single-use medical gloves. Constructed from vinyl and oil-based liquid nitrile rubber, they function as a physical barrier to prevent contamination between patients and examiners. Used in clinical settings, the gloves are worn by healthcare providers during examinations. The device is evaluated against ASTM D5250-06 (2011) standards for physical dimensions, tensile strength, elongation, and pinhole resistance. Biocompatibility is confirmed via primary skin irritation and dermal sensitization assays. The gloves provide a protective barrier, reducing the risk of cross-contamination during routine medical procedures.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including physical property testing (tensile strength, elongation, dimensions, pinhole resistance per ASTM D5250-06) and biocompatibility testing (primary skin irritation and dermal sensitization per ISO 10993-10).

Technological Characteristics

Materials: Vinyl and oil-based liquid nitrile rubber. Form factor: Disposable, non-sterile, powder-free examination glove. Standards: ASTM D5250-06 (2011). Biocompatibility: ISO 10993-10. Physical properties: Tensile strength (15.2 MPa before aging), ultimate elongation (390% before aging), pinhole AQL 1.5.

Indications for Use

Indicated for use as a disposable, non-sterile patient examination glove worn on the examiner's hand or finger 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

• Grand Work Plastic Products Co., Ltd. Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color (K061562)

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 human figure or a caduceus, with three overlapping profiles facing to the right.

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

December 5,2014

Grand Work Plastic Products Company Limited C/O Ms. Kathy Liu Hongray USA Medical Products Incorporated 3973 Schaefer Avenue Chino, CA 91710

Re: K142409

Trade/Device Name: Vinyl Co-Polymer Powder-free Examination Gloves, Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: October 31, 2014 Received: November 5, 2014

Dear Ms. Liu:

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 - Ms. Liu

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,

Susan Runco, DDS, MA

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

510(k) Number (if known) K142409

Device Name

Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color

Indications for Use (Describe)

A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand 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)

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

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Donggao Industrial Zone Zanhuang, Hebei, China 050000

K142409

### 510(K) SUMMARY

This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR \$807.92.

The assigned 510(K) number is: K142409

Date Summary Prepared: December 3, 2014

#### 1. Owner's Identification:

Grand Work Plastic Products Co., Ltd. Donggao Industrial Zone Zanhuang, Hebei, China 050000 Tel: [phone] Fax: [phone] Contact: Ms. May Jia Position title: Project Manager

#### 2. Name of the Device:

Trade Name: Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color Common Name: Exam Gloves Classification Name: Patient Examination Glove Classification Regulation: 880.6250 Classification Panel: 880 General Hospital Product Code: LYZ Device Class: Class I

#### 3. Predicate Device Information:

Grand Work Plastic Products Co., Ltd. Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color (K061562)

#### 4. Device Description:

Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl and oil-based liquid nitrile rubber materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-06 (Reapproved 2011) Standard Specification For Poly (Vinyl Chloride) Gloves For Medical Application.

#### 5. Intended Use of the Device:

A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

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Donggao Industrial Zone Zanhuang, Hebei, China 050000

K142409

## 6. Technological Characteristics and Substantial Equivalence:

Grand Work Plastic Products Co., Ltd.'s Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color is substantially equivalent in safety and effectiveness to the Grand Work Plastic Products Co., Ltd. 's Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color (K 061562). The subject device and predicate device use a similar plastic flexible barrier film to achieve a device for the intended use.

And the properties between the subject device and the predicate device are compared in the following table:

| Characteristics | Device Performance | | Result of<br>comparison | |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|-----------------------------------------------------|
| | Predicate device<br>K061562 | Subject Device<br>K142409 | | |
| Product Code | LYZ | LYZ | Similar | |
| Indications For Use | Predicate device is<br>disposable non-sterile<br>device intended for medical<br>purpose that is worn on the<br>examiner's hand or finger to<br>prevent contamination<br>between patient and<br>examiner. | Subject device is disposable<br>non-sterile device intended<br>for medical purpose that is<br>worn on the examiner's<br>hand or finger to prevent<br>contamination between<br>patient and examiner. | Similar | |
| Labeling | It is Patient Examination<br>Glove, Disposable, single<br>use only and non-sterile | It is Patient Examination<br>Glove, Disposable, single<br>use only and non-sterile | Similar | |
| Device Materials | Vinyl and oil-based liquid<br>Nitrile compound<br>The plasticizer type used is<br>different. | Vinyl and oil-based liquid<br>Nitrile compound<br>The plasticizer type used is<br>different. | Similar | |
| Color | Blue | Blue | Similar | |
| Characteristics | Stated<br>Standard | Device Performance | | Result of<br>comparison |
| | | Predicate device<br>K061562 | Subject Device<br>K142409 | |
| Tensile strength:<br>before and after<br>aging | K061562:<br>9Mpa min<br>K142409<br>11Mpa min | Before aging:14 MPa<br>After aging:14MPa | Before aging:<br>15.2Mpa<br>After aging:<br>14.6Mpa | Similar &<br>Both meet<br>ASTM<br>D5250<br>standard |

evice tolerances and specifications & Performance Data:

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Donggao Industrial Zone Zanhuang, Hebei, China 050000

# K142409

| Characteristics | Stated<br>Standard | Device Performance | | Result of<br>comparison |
|------------------------------------------------------|-----------------------------------|------------------------------------------------------|------------------------------------------------------|-----------------------------------------------------|
| | | Predicate device<br>K061562 | Subject Device<br>K142409 | |
| Ultimate<br>elongation:<br>before and after<br>aging | 300% min | Before aging: 400%<br>After aging:300% | Before aging: 390%<br>After aging: 360% | Similar &<br>Both meet<br>ASTM<br>D5250<br>standard |
| Freedom from<br>pinholes | G-I,<br>AQL2.5 | G-I, AQL2.5 | G-I, AQL1.5 | Similar &<br>Both meet<br>ASTM<br>D5250<br>standard |
| Overall length | 230 for all<br>sizes min | 245mm | 239mm | |
| Width | S: 85±5 | 82 mm | 87 mm | Similar &<br>Both meet<br>ASTM<br>D5250<br>standard |
| | M: 95±5 | 97mm | 97 mm | |
| | L: 105±5 | 110mm | 107 mm | |
| | XL: 115±5 | 120mm | 118 mm | |
| Palm thickness | min0.08mm | 0.10mm | 0.08mm | |
| Finger thickness | min0.05mm | 0.10mm | 0.10mm | |
| Residual powder | Not more<br>than 2mg<br>per glove | Not more than 2mg<br>per glove | Not more than 2mg<br>per glove | Similar &<br>Both meet<br>ASTM<br>D5250<br>standard |
| Biocompatibility | | | | |
| Primary skin<br>irritation test | ISO 10993-<br>10 | Under conditions of<br>the study, not an<br>irritant | Under conditions of<br>the study, not an<br>irritant | Similar |
| Dermal<br>sensitization assay | ISO 10993-<br>10 | Under conditions of<br>the study, not an<br>irritant | Under conditions of<br>the study, not an<br>irritant | Similar |

The two versions of standards referenced for predicate device and subject device are compared in the following table:

| Testing Items | ASTM D5250-00ε 4<br>for Predicate device<br>K061562 | ASTM D 5250-06(2011)<br>for Subject Device<br>K142409 | Inspection<br>level | Result of<br>comparison |
|----------------|-----------------------------------------------------|-------------------------------------------------------|---------------------|-------------------------|
| Overall Length | 230 for all sizes min | 230 for all sizes mini | S-2, AQL4.0 | Same |

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Donggao Industrial Zone Zanhuang, Hebei, China 050000

### K142409

| (mm) | | | | |
|----------------------------|--------------------------------|--------------------------------|-------------|--------|
| Width<br>(mm) | S: 85±5 | S: 85±5 | S-2, AQL4.0 | Same |
| | M: 95±5 | M: 95±5 | | |
| | L: 105±5 | L: 105±5 | | |
| | XL: 115±5 | XL: 115±5 | | |
| Palm Thickness<br>(mm) | 0.08mm min | 0.08mm min | S-2, AQL4.0 | Same |
| Finger<br>Thickness (mm) | 0.05mm min | 0.05mm min | S-2, AQL4.0 | Same |
| Tensile Before<br>aging | 9Mpa min | 11Mpa min | | Exceed |
| Tensile After<br>aging | 9Mpa min | 11Mpa min | S-2, AQL4.0 | Exceed |
| Elongation<br>Before aging | 300% min | 300% min | | Same |
| Elongation After<br>aging | 300% min | 300% min | S-2, AQL4.0 | Same |
| Pinhole | AQL 2.5 | AQL 2.5 | G-I | Same |
| Residual<br>Powder | Not more than 2mg<br>per glove | Not more than 2mg per<br>glove | N=5 | Same |

Grand Work Plastic Products Co., Ltd. 's Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color shares the same or comparable technology characteristics compared to the predicate device. The subject device performs according to the glove performance standards ASTM D5250-06(2011), biocompatibility requirement and FDA requirements and the labeling claims for the product. It performs as well as the legally marketed predicate device.

# 7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as Follows:

| Testing Items | FDA-recognized<br>Standard<br>Requirements | Inspection Level<br>and AQL | Testing Results | Conclusion |
|------------------------|--------------------------------------------|-----------------------------|-----------------|------------|
| Overall Length<br>(mm) | 230 for all sizes<br>min | S-2, AQL4.0 | 239mm | Pass |
| Width<br>(mm) | S: 85±5 | S-2, AQL4.0 | S: 87 | Pass |
| | M: 95±5 | | M: 97 | |
| | L: 105±5 | | L: 107 | |
| | XL: 115±5 | | XL: 118 | |

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Donggao Industrial Zone Zanhuang, Hebei, China 050000

### K142409

| Palm Thickness<br>(mm) | 0.08mm min | S-2, AQL4.0 | 0.08mm | Pass |
|--------------------------------------|---------------------------------------------------|-------------|---------------------------------------------------|------|
| Finger Thickness<br>(mm) | 0.05mm min | S-2, AQL4.0 | 0.10mm | Pass |
| Tensile Strength (Mpa) | | | | |
| Before aging | 11Mpa min | S-2, AQL4.0 | 15.2Mpa min | Pass |
| After aging | 11Mpa min | S-2, AQL4.0 | 14.6Mpa min | Pass |
| Ultimate Elongation (%) | | | | |
| Before aging | 300% min | S-2, AQL4.0 | 390% min | Pass |
| After aging | 300% min | S-2, AQL4.0 | 360% min | Pass |
| Pinhole | 2.5 | G-I | AQL1.5 | Pass |
| Residual Powder | Not more than 2mg<br>per glove | N=5 | Not more than 2mg<br>per glove | Pass |
| (a) Primary Skin<br>Irritation Test | Under conditions of the study, not an<br>irritant | | Under conditions of the study, not an<br>irritant | |
| (b) Dermal<br>Sensitization<br>Study | Under conditions of the study, not an<br>irritant | | Under conditions of the study, not an<br>irritant | |

# 8. Discussion of Clinical Tests Performed:

Not Applicable

# 9. Labeling:

It is Patient Examination Glove, Disposable, single use only and non-sterile There are no special labeling claims.

# 10. Conclusions:

Grand Work Plastic Products Co., Ltd's Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color conform fully to ASTM D 5250-06 ( 2011 ) standard as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data discussed above. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.

Drawn from the complete list of non-clinical tests, the device herein mentioned is as safe, as effective, and performs as well as the legally marketed predicate device.