Powder Free Vinyl Patient Examination Gloves (Yellow, White)

K180260 · Shanxi Hongjin Plastic Technology Co., Ltd. · LYZ · Jun 12, 2018 · General Hospital

Device Facts

• Record ID: K180260
• Device Name: Powder Free Vinyl Patient Examination Gloves (Yellow, White)
• Applicant: Shanxi Hongjin Plastic Technology Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Jun 12, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended 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

Disposable, non-sterile vinyl patient examination gloves; intended for use by healthcare examiners to prevent cross-contamination between patient and examiner. Device is worn on hands or fingers. Manufactured in yellow and white. Performance meets ASTM D5250-06 (2015) standards for physical properties, dimensions, tensile strength, and freedom from pinholes. Biocompatibility testing confirms non-irritant, non-sensitizing, and non-cytotoxic properties. Used in clinical or medical settings.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM D5250-06 (2015) for dimensions, physical properties (tensile strength, elongation), pinhole rate (AQL 2.5), and residual powder. Biocompatibility testing included primary skin irritation, dermal sensitization, and cytotoxicity assays.

Technological Characteristics

Material: Vinyl. Form factor: Disposable, non-sterile, powder-free examination glove. Standards: ASTM D5250-06 (2015). Residual powder: ≤ 2 mg per glove. Biocompatibility: Non-irritant, non-sensitizing, non-cytotoxic.

Indications for Use

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

• Ever Light Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) (K142570)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 12, 2018

Shanxi Hongjin Plastic Technology Co., Ltd % Kathy Liu Project Manager Hongray USA Medical Products Inc 3973 Schaefer Ave., Chino, CA 91710 US

Re: K180260

Trade/Device Name: Powder Free Vinyl Patient Examination Gloves (Yellow, White) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: May 16, 2018 Received: May 30, 2018

Dear Kathy 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.

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 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);

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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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## Indications for Use

510(k) Number (if known) K180260

#### Device Name

Powder Free Vinyl Patient Examination Gloves (Yellow, White)

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)

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

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Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province, China 042399

Product: Powder Free Vinyl Patient Examination Gloves (Yellow, White)

#### 510(K) SUMMARY

The assigned 510(K) number is: K180260

#### 1. Owner's Identification :

Mr. Wu Zhigang Shanxi Hongjin Plastic Technology Co., LTD Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province, China 042399

Tel: [phone] Fax: [phone]

Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: [phone] Fax: [phone] Date Summary Prepared: May 16, 2018

#### 2.Name of the Device:

Trade Name: Powder Free Vinyl Patient Examination Gloves (Yellow, White) Common Name: Exam Gloves Classification Name: Patient Examination Glove Classification Regulation: 880.6250 Classification Panel: 880 General Hospital and Personal Use Product Code: LYZ Device Class: Class I

#### 3. Predicate Device Information:

Ever Light Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) (K142570)

#### 4. Device Description:

Powder Free Vinyl Patient Examination Gloves (Yellow, White) are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-06 (Reapproved 2015) Standard Specification For Poly (Vinyl Chloride) Gloves For Medical Application.

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Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province, China 042399

Product: Powder Free Vinyl Patient Examination Gloves (Yellow, White)

#### 5. Indications for Use Statement for these Devices:

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.

### 6. Technological Characteristics Comparison:

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 | Subject Device | |
| Product Code | LYZ | LYZ | Same |
| Intended Use | Predicate device is<br>disposable non-sterile<br>device intended for<br>medical purpose that is<br>worn on the examiner's<br>hand or finger to prevent<br>contamination between<br>patient and examiner. | Subject device is<br>disposable non-sterile<br>device intended for<br>medical purpose that is<br>worn on the examiner's<br>hand or finger to prevent<br>contamination between<br>patient and examiner. | Same |
| Labeling | There are no special<br>labeling claims | There are no special<br>labeling claims | Same |
| Device Materials | Vinyl | Vinyl | Same |
| Color | Yellow White Blue Pink | Yellow White | Different |
| Specifications & Performance Data: | | | |
| physical Properties | Meets ASTM D 5250-06<br>(2015) requirements | Meets ASTM D 5250-06<br>(2015) requirements | Same |
| Freedom from<br>pinholes | Meets ASTM D 5250-06<br>(2015) requirements | Meets ASTM D 5250-06<br>(2015) requirements | Same |
| Dimensions: | Meets ASTM D 5250-06<br>(2015) requirements | Meets ASTM D 5250-06<br>(2015) requirements | Same |
| Residual powder | Meets Applicable<br>Definition for Powder<br>Free; ≤ 2 mg per glove | Meets Applicable<br>Definition for Powder<br>Free; ≤ 2 mg per glove | Same |
| Biocompatibility | | | |
| Primary skin<br>irritation test | Under conditions of the<br>study, not an irritant | Under conditions of the<br>study, not an irritant | Same |
| Dermal | Under conditions of the<br> | Under conditions of the<br> | Same |

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Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province, China 042399

Product: Powder Free Vinyl Patient Examination Gloves (Yellow, White)

| Characteristics | Device Performance | | Result of<br>comparison |
|------------------------|-------------------------|-------------------------|-------------------------|
| | Predicate device | Subject Device | |
| sensitization<br>assay | study, not a sensitizer | study, not a sensitizer | |

Shanxi Hongjin Plastic Technology Co., Ltd's Powder Free Vinyl Patient Examination Gloves (Yellow, White) 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(2015), biocompatibility requirement and FDA requirements and the labeling claims for the product.

#### 7. Discussion of Non-Clinical Performance Tests

| Testing Items | FDA-recognized<br>Standard<br>Requirements | Inspection<br>Level and<br>AQL | Actual Testing<br>Results | Conclusion | |
|-------------------------------|---------------------------------------------|--------------------------------|-------------------------------------------------------------|------------------------------|--------------|
| Overall Length<br>(mm) | 230 for all sizes<br>minimum | S-2, AQL4.0 | S: 233-244mm<br>M:231-241mm<br>L:230-243mm<br>XL: 234-242mm | Pass | |
| Width<br>(mm) | S: 85±5<br>M: 95±5<br>L: 105±5<br>XL: 115±5 | S-2, AQL4.0 | 87-88 mm<br>97-98 mm<br>107-108 mm<br>118-119 mm | Pass | |
| Palm<br>Thickness<br>s (mm) | 0.08mm<br>minimum | S-2, AQL4.0 | 0.08mm | Pass | |
| Finger<br>Thickness<br>s (mm) | 0.05mm<br>minimum | S-2, AQL4.0 | 0.09-0.12mm | Pass | |
| Tensile Strength (Mpa) | Before aging<br>After aging | S-2, AQL4.0 | 11Mpa minimum<br>11Mpa minimum | 15.1-18.1Mpa<br>14.9-17.7Mpa | Pass<br>Pass |
| Ultimate Elongation (%) | Before aging<br>After aging | S-2, AQL4.0 | 300% minimum<br>300% minimum | 390-470%<br>380-490% | Pass<br>Pass |
| Pinhole | 2.5 | G-I | meet AQL2.5<br>requirements | Pass | |
| Residual | Not more than | N=5 | 0.18 mg/glove | Pass | |

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Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province, China 042399

Product: Powder Free Vinyl Patient Examination Gloves (Yellow, White)

| Powder | 2mg per glove | | |
|----------------------------------|------------------------------------------------------------------|------------------------------------------------------------------|--|
| Primary Skin<br>Irritation Test | Under conditions of the study, not<br>an irritant | Under conditions of the study, not<br>an irritant | |
| Dermal<br>Sensitization<br>Study | Under conditions of the study, not<br>a sensitizer | Under conditions of the study, not<br>a sensitizer | |
| Cytotoxicity<br>Test | Under the conditions of this<br>study, not a cytotoxic potential | Under the conditions of this study,<br>not a cytotoxic potential | |

#### 8.Clinical Performance Tests:

Clinical testing is not needed for this device.

#### 9._Conclusion:

Shanxi Hongjin Plastic Technology Co., Ltd's Powder Free Vinyl Patient Examination Gloves (Yellow, White) conform fully to ASTM D 5250-06 (2015) standard as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data discussed above. Based on the performed nonclinical tests, the device is as safe, as effective, and performs as well as the legally marketed predicate device.