Vinyl Exam Gloves, Powder Free, Clear

K161390 · Zibo Hongchin Plastic and Rubber Co., Ltd. · LYZ · Dec 19, 2016 · General Hospital

Device Facts

• Record ID: K161390
• Device Name: Vinyl Exam Gloves, Powder Free, Clear
• Applicant: Zibo Hongchin Plastic and Rubber Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Dec 19, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.

Device Story

Vinyl examination gloves; disposable; non-sterile; ambidextrous. Worn by healthcare examiners on hands/fingers to provide a physical barrier against contamination. Used in clinical settings for surface contact (<24 hours). Protects both patient and examiner by preventing transmission of contaminants. No electronic or software components.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM D5250-06 (dimensions, physical properties), ASTM D6124-06 (residual powder), and ASTM D5151-06 (pinhole/barrier integrity). Biocompatibility testing confirmed no primary skin irritation or sensitization.

Technological Characteristics

Material: Polyvinyl Chloride (PVC). Form factor: Ambidextrous, disposable glove. Dimensions: 230mm length, 94mm palm width, 0.09mm palm thickness, 0.085mm fingertip thickness. Standards: ASTM D5250-06, ASTM D6124-06, ASTM D5151-06. Biocompatibility: ISO 10993-10. Non-sterile.

Indications for Use

Indicated for use as a disposable medical glove worn by examiners 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

• Vinyl Examination Gloves Powder-Free (K022091)

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" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing right, with flowing lines that could be interpreted as hair or clothing.

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

December 19, 2016

Zibo Hongchin Plastic and Rubber Co., Ltd % Ms. Sophie Hao Official Correspondent Basic Medical Industries, Inc. 805 Barrington Ave Ontario, CA 91764

Re: K161390

Trade/Device Name: Vinyl Exam Gloves, Powder Free, Clear Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: November 2, 2016 Received: November 10, 2016

Dear Ms. Hao:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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,

Michael J. Ryan -S

for Tina Kiang, PhD 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) KIJ1390

Device Name

Vihyl Exam Gloves, Powder Free, Clear

Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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K161390

# 510 (K) SUMMARY

#### 1. Submitter's Identification:

Zibo Hongchin Plastic and Rubber Co.,Ltd No 17 Yingxiong Rd, Zhangdian District, Zibo Shandong, 255400 China

Date summary prepared: December 8, 2016

#### 2. Name of the Device:

Zibo Hongchin Plastic and Rubber Co.,Ltd Vinyl Exam Gloves, Powder Free, Clear

## 3. Common name/classification name of the Device: Patient Examination Gloves Device Class: Class I Regulation number: 21 CFR 880.6250 Product code: LYZ

#### 4. Contact Person:

James Ren, Product Manager Phone: # [phone] Zibo Hongchin Plastic and Rubber Co.,Ltd No 17 Yingxiong Rd, Zhangdian District, Zibo Shandong, 255400 China

### Predicate Device Information: ક.

Device name: Vinyl Examination Gloves Powder-Free 510(K) #: K022091 Manufacturer name: Tangshan Zhonghong Pulin Food Products Co., Ltd

#### 6. Device Description:

Subject device: Vinyl Exam Gloves, Powder Free, Clear Device Class: Class I Regulation number: 21 CFR 880.6250 Product code: LYZ Length: 230 mm min Width: 94 mm min Palm Thickness: 0.09 mm min Fingertip Thickness: 0.085 mm min

Tensile Strength (Mpa) Before aging 16.96Mpa average After aging 14.92Mpa average

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Ultimate Elongations Before aging 519% average After aging 480% average

Device functions: As a barrier, the subject device prevents contamination between patient and examiner

#### 7. Indication for Use:

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner

#### 8. Comparison to Predicate Devices:

Zibo Hongchin Plastic and Rubber Co., Ltd Vinyl Exam Gloves, Powder Free, Clear are substantially equivalent in safety and effectiveness to the Zhonghong Pulin Food Products Co., Ltd Vinyl Examination Gloves, Powder-Free. (K022091)

| | Proposed Device | Predicate Device (K022091) | COMMENTS |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| The device | Zibo Hongchin Plastic and<br>Rubber Co.,Ltd Vinyl Exam<br>Gloves, Powder Free, Clear | Vinyl Examination Gloves,<br>Powder-Free Tangshan<br>Zhonghong Pulin Food<br>Products Co., Ltd | |
| Regulation # | 21 CFR 880.6250 | 21 CFR 880.6250 | Similar |
| Device Class | Class I | Class I | Similar |
| Product Code: | LYZ | LYZ | Similar |
| Indications for<br>Use | A patient examination glove is<br>a disposable device intended<br>for medical purposes that is<br>worn upon the examiner's<br>hands or fingers to prevent<br>contamination between patient<br>and examiner | A patient examination glove<br>is a disposable device<br>intended for medical<br>purposes that is worn upon<br>the examiner's hands or<br>fingers to prevent<br>contamination between<br>patient and examiner | Similar |
| Basic Design | Cover the hand and wrist area.<br>Clovers have separate sheaths<br>or openings for each finger<br>and the thumb. | Cover the hand and wrist<br>area. Clovers have separate<br>sheaths or openings for each<br>finger and the thumb. | Similar |
| Device Materials | Poly Vinyl Chloride | Poly Vinyl Chloride | Similar |
| Residual Powder | <2 mg per glove and meet the<br>requirement of ASTM D6124-<br>06. | <2 mg per glove | Similar |
| Length on<br>Medium Size | 230 mm min | 230 mm min | Similar |
| Width of Palm on<br>Medium Size | 94 mm min | 94 mm min | Similar |
| Palm Thickness | 0.09 mm min | 0.09 mm min | Similar |
| Fingertip<br>Thickness | 0.085 mm min | 0.085 mm min | Similar |
| Tensile<br>Strength(Mpa)<br>and Ultimate<br>Elongations<br>Before Aging: | 16.96 average (Tensile<br>strength)<br>519% average (elongated rate)<br>Meet requirement under<br>ASTM D5250-06 | 16.96 average (Tensile<br>strength)<br>519% average (elongated<br>rate)<br>Meet requirement under<br>ASTM D5250-06 | Similar |
| Tensile<br>Strength(Mpa)<br>and Ultimate<br>Elongations After<br>Aging: | 14.92 average (Tensile<br>strength)<br>480% average (elongated rate)<br>Meet requirement under<br>ASTM D5250-06 | 14.92 average (Tensile<br>strength)<br>480% average (elongated<br>rate)<br>Meet requirement under<br>ASTM D5250-06 | Similar |
| Pinhole Results | AQL 2.5, met per ASTM<br>D5151-06 | AQL 2.5 | Similar |
| Primary Skin<br>Irritation<br>Per ISO-10993-10 | Not an irritant under the<br>condition of study | Not an irritant under the<br>condition of study | Similar |
| Dermal<br>Sensitization | Not a sensitizer under the<br>condition of study | Not a sensitizer under the<br>condition of study | Similar |
| Labeling | Labels include: Product name;<br>Non-sterile; color; "single use<br>Only" size, Quantity,<br>ambidextrous, lot number,<br>distributor name, indication<br>for use and manufacturer<br>address. | Labels include: Product<br>name; Non-sterile; color;<br>"single use" size, Quantity,<br>ambidextrous, distributor<br>name, indication for use and<br>manufacturer address. | Similar |
| Substantially<br>equivalent<br>comparison | Powder-free Vinyl Patient Examination Glove, the subject device in K161390, has<br>similar intended use and is substantially equivalent to the predicate device<br>(K022091), | | |

## Table 7-2. Side-by-Side Comparison of Intended Use, Design, Material, Physical, Biocompatibility, and Performance Testing

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# K161390

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### 9. Discussion of Non-Clinical tests performed for Determination of Substantial Equivalence are as follows:

The standards used for Zibo Hongchin Plastic and Rubber Co.,Ltd glove production are based on ASTM-D-5250-06. All testing meets requirements for dimensions, physical properties, barrier properties and powder under ASTM-D-5250-06. Physical property test conducted on gloves meets Inspection Level S-2, AQL 2.5.

The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level I, meeting these requirements.

Biocompatibility test results showing no primary skin irritation or sensitization under the conditions of study.

#### 10. Patient Contact

The glove is available for surface-contacting with less than 24 hours duration.

#### 11. Sterilization

Subject device is non-sterile examination gloves for single use.

#### 12. Discussion of Clinical Tests Performed:

Not Applicable

#### 13. Conclusions:

The Zibo Hongchin Plastic and Rubber Co., Ltd Vinyl Exam Gloves, Powder Free, Clear are substantially equivalent to the predicate Vinyl Powder Free Examination Glove cleared under K022091.