Powder Free Vinyl Patient Examination Gloves

K180381 · Shanxi Hongjin Plastic Technology Co., Ltd. · LYZ · Nov 7, 2018 · General Hospital

Device Facts

• Record ID: K180381
• Device Name: Powder Free Vinyl Patient Examination Gloves
• Applicant: Shanxi Hongjin Plastic Technology Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Nov 7, 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; worn on examiner's hand or finger; prevents cross-contamination between patient and examiner. Used in clinical settings; operated by healthcare professionals. Device provides physical barrier protection. Benefits include reduced risk of contamination during medical examinations.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM D5250-06 (2015) standards for dimensions, physical properties (tensile strength, elongation), freedom from pinholes, residual powder, and biocompatibility (primary skin irritation, dermal sensitization, and cytotoxicity).

Technological Characteristics

Vinyl material; powder-free; non-sterile. Dimensions and physical performance meet ASTM D5250-06 (2015) standards. Tensile strength ≥ 11 MPa; elongation ≥ 300%. Freedom from pinholes AQL 2.5. Residual powder ≤ 2 mg/glove. Biocompatible (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 (K142571)

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

November 7, 2018

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

Re: K180381

Trade/Device Name: Powder Free Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: September 26, 2018 Received: October 2, 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,

# Clarence W. Murray lii III -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) K180381

Device Name

Powder Free Vinyl Patient Examination Gloves

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

Trade Name: Powder Free Vinyl Patient Examination Gloves

#### 510(K) SUMMARY

This summary of 510(K) is being submitted in accordance with 21 CFR 807.92.

The assigned 510(K) number is: K180381

#### 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 or Ms Monica Yu Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: [phone] Fax: [phone] Date Summary Prepared: November 5, 2018

#### 2. Name of the Device:

Trade Name: Powder Free Vinyl Patient Examination Gloves 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 (K142571)

#### 4. Device Description:

Powder Free Vinyl Patient Examination Gloves 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

Trade Name: Powder Free Vinyl Patient Examination Gloves

## 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.

### 6. Technological Characteristic Comparison Table:

Shown below is the comparison of technological characteristic between the subject and predicate device.

| Characteristics | Device Performance | | Result of<br>comparison |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| | Predicate device<br>K142571 | Subject Device K180381 | |
| 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 | Clear | Clear | Similar |
| Specifications & Performance Data: | | | |
| physical Properties | 11Mpa minimum<br>Elongation 300%<br>Meets ASTM D 5250-06<br>(2015)requirements | 11Mpa minimum<br>Elongation:300%<br>Meets ASTM D 5250-06<br>(2015)requirements | Same |
| Freedom from<br>pinholes | G -1,AQL 2.5<br>Meets ASTM D 5250-06<br>(2015)requirements | G -1,AQL 2.5<br>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<br>Primary skin | Under conditions of the | Under conditions of the | Same |

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

Trade Name: Powder Free Vinyl Patient Examination Gloves

| | Device Performance | | Result of |
|----------------------------------|---------------------------------------------------|---------------------------------------------------------------------|------------|
| Characteristics | Predicate device<br>K142571 | Subject Device K180381 | comparison |
| irritation test | study, not an irritant | study, not an irritant | |
| Dermal<br>sensitization<br>assay | Under conditions of the<br>study, not an irritant | Under conditions of the<br>study, not an irritant | Same |
| Cytotoxicity Test | / | Under the conditions of<br>this study, not a cytotoxic<br>potential | Different |

Shanxi Hongjin Plastic Technology Co., Ltd's Powder Free Vinyl Patient Examination Gloves shares the same or similar technology characteristics compared to the predicate device.

### 7. Discussion of Non-Clinical Tests

| Testing Items | FDA-recognized<br>Standard<br>Requirements | Inspection<br>Level and AQL | Actual Testing<br>Results | Conclusion |
|-----------------------------|--------------------------------------------|-----------------------------|-------------------------------------------------------------|------------|
| Overall<br>Length<br>(mm) | 230 for all sizes<br>minimum | S-2, AQL4.0 | S: 233-241mm<br>M:231-242mm<br>L:230-244mm<br>XL: 234-245mm | Pass |
| Width<br>(mm) | S: 85 ± 5 | S-2, AQL4.0 | 87-88 mm | Pass |
| | M: 95 ± 5 | | 97-98 mm | |
| | L: 105±5 | | 107-108 mm | |
| | XL: 115±5 | | 118-119 mm | |
| Palm<br>Thickness<br>(mm) | 0.08mm<br>minimum | S-2, AQL4.0 | 0.08mm | Pass |
| Finger<br>Thickness<br>(mm) | 0.05mm<br>minimum | S-2, AQL4.0 | 0.09-0.11mm | Pass |
| Tensile Strength (Mpa) | | | | |
| Before aging | 11Mpa minimum | S-2, AQL4.0 | 14.4-17.1Mpa | Pass |
| After aging | 11Mpa minimum | | 14.1-16.9Mpa | Pass |
| Ultimate Elongation (%) | | | | |
| Before aging | 300% minimum | S-2, AQL4.0 | 390-480% | Pass |
| After aging | 300% minimum | | 380-470% | Pass |

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

| Pinhole | 2.5 | G-I | meet AQL2.5 requirements | Pass |
|----------------------------------------|------------------------------------------------------------------|-----|------------------------------------------------------------------|------|
| Residual<br>Powder | Not more than<br>2mg per glove | N=5 | 0.20 mg/glove | Pass |
| (a) Primary<br>Skin<br>Irritation Test | Under conditions of the study, not<br>an irritant | | Under conditions of the study, not<br>an irritant | |
| (b) Dermal<br>Sensitization<br>Study | Under conditions of the study, not<br>an irritant | | Under conditions of the study, not<br>an irritant | |
| (c)Cytotoxicity<br>Test | Under the conditions of this study,<br>not a cytotoxic potential | | Under the conditions of this study,<br>not a cytotoxic potential | |

Trade Name: Powder Free Vinyl Patient Examination Gloves

## 8. Discussion of Clinical Tests Performed:

Not applicable

## 9. Conclusion:

Based on the performed nonclinical tests, demonstrate that the device is as safe, as effective, and performs as well as the legally marketed predicate device.