Clear Vinyl Powder-free Patient Examination Gloves

K171317 · Shandong Zhi Hong Medical Products, Co. , Ltd. · LYZ · Sep 11, 2017 · General Hospital

Device Facts

• Record ID: K171317
• Device Name: Clear Vinyl Powder-free Patient Examination Gloves
• Applicant: Shandong Zhi Hong Medical Products, Co. , Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Sep 11, 2017
• 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 on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Non-sterile, clear, powder-free vinyl patient examination gloves; worn by healthcare examiners on hands or fingers; function as physical barrier to prevent contamination between patient and examiner; disposable; intended for medical use.

Clinical Evidence

Bench testing only. No clinical data. Performance verified via ASTM D-5250-06 (physical/dimensions), ASTM D-6124-06 (residual powder <2mg/pc), ASTM D-5151-06 (pinhole/water fill test, AQL 2.5), and biocompatibility testing (primary skin irritation and sensitization).

Technological Characteristics

Material: Vinyl (PVC). Standards: ASTM D-5250-06, ASTM D-6124-06, ASTM D-5151-06. Dimensions: Length 230mm min, Width 94mm min, Palm thickness 0.09mm min, Fingertip thickness 0.086mm min. Physical properties: Tensile strength (before aging 15MPa min, after 13MPa min), Ultimate elongation (before 495% min, after 415% min). Non-sterile, powder-free.

Indications for Use

Indicated for use as a disposable medical 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

• Powder-free PVC Vinyl Exam Gloves, Hebei Grandeast Plastic Products Co., Ltd. (K142703)

Submission Summary (Full Text)

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

September 11, 2017

Shandong Zhi Hong Medical Products, Co. Ltd. % Melo Zhang Official Correspondent Intco Medical Industries, INC. 805 Barrington Ave Ontario, California 91764

Re: K171317

Trade/Device Name: Clear Vinyl Powder-free Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: August 21, 2017 Received: August 23, 2017

Dear Melo Zhang:

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

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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 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 (DICE) 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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely, Tara A. Ryan -S 2017.09.11 19:39:48 -04'00' for Lori Wiggins, MPT, CLT 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) K171737

Device Name

Clear Vinyl Powder-free Patient Examination Gloves

Indications for Use (Describe)

A 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.

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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# Shandong Zhi Hong Medical Products, Co. Ltd.

231 Dongqi Industrial Park Qingzhou City, Shandong China

# 510(K) SUMMARY

#### Submitter / 510(k) Sponsor

Shandong Zhi Hong Medical Products, Co. Ltd. 231 Dongqi Industrial Park Qingzhou City, Shandong China

#### Contact Person

Melo Zhang Official Correspondent Phone: [phone] Email: [e-mail]

#### Summary Preparation Date

Sept 5, 2017

Type of 510(k) Submission

Traditional

#### Device Name / Classification

Name of Device: Clear Vinyl Powder-free Patient Examination Gloves Proprietary Name: Powder-Free Vinyl Patient Examination Gloves Common Name: Vinyl Patient Examination Glove Classification Name: Patient Examination Glove Product Code: LYZ Product Class: Class I Regulation #: 21 CFR 880.6250 Classification Panel: General Hospital

#### Predicate Device

Powder-free PVC Vinyl Exam Gloves, Hebei Grandeast Plastic Products Co., Ltd. K142703

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Image /page/4/Picture/0 description: The image contains the logo and name of a company. The logo is on the left side of the image and appears to be a stylized graphic. To the right of the logo is the text "Shandong Zhi Hong Medical Products, Co. Ltd." The text is in a bold, serif font, and the company name is underlined.

231 Dongqi Industrial Park Qingzhou City, Shandong China

#### Device Description

The proposed devices, Powder-free Vinyl Exam Gloves are non-sterile, clear, noncolored and disposable medical gloves intended to be worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

### Non Clinical Performance Tests

Scientific concepts: The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level I, to prevent contamination between patient and examiner; Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.

Significant physical and performance characteristics of the device: glove production is based on ASTM-D-5250-06. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AOL 2.5.

Subject Clear Vinyl Powder-free Patient Examination Gloves do not contain any USP powder per the results of testing conducted on the gloves. The residual powder testing is conducted per standards of ASTM D-6124-06, which demonstrates that the powder free glove is less than 2mg/pc. Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80L YZ, and meets all requirement of ASTM Standard D5250-06.

Overall Length: 230mm min Width: 94mm min Palm Thickness: 0.09 mm min Fingertip Thickness: 0.086 mm min Tensile Strength (Mpa) Before aging 15Mpa min After aging 13Mpa min Ultimate Elongations Before aging 495% min After aging 415% min

#### Indications for Use

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

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# Shandong Zhi Hong Medical Products, Co. Ltd.

231 Donggi Industrial Park Qingzhou City, Shandong China

TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES

| Device<br>Characteristics | Proposed Device | Predict Device<br>(K142703) | Comparison<br>Conclusion |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Product Name | Shandong Zhi Hong Medical<br>Products, Co. Ltd.<br>Clear Vinyl Powder-free<br>Patient Examination Gloves, | Hebei Grandeast Plastic<br>Products Co., Ltd.<br>Glide-On Vinyl<br>Examination Gloves | |
| Product Code | LYZ | LYZ | Similar |
| Intended Use | Disposable device intended for<br>medical purposes that is worn<br>on the examiner's hand or<br>finger to prevent<br>contamination between patient<br>and examiner | Disposable device<br>intended for medical<br>purposes that is worn on<br>the examiner's hand or<br>finger to prevent<br>contamination between<br>patient and examiner | Similar |
| Length on Large<br>Size | Average over 232.23mm | Average over 230mm | Similar |
| Width of Palm on<br>Large Size | Average 95mm | Average 95mm | Similar |
| Palm Thickness | Average 0.095 mm | Average 0.095 mm | Similar |
| Fingertip Thickness | Average 0.09 mm | Average 0.09 mm | Similar |
| Residual Powder | According to ASTM D6124-06<br>Standard Test Method for<br>Residual Powder on Medical<br>gloves for the determination of<br>residual powder content.<br>Testing result indicates the<br>weight of all types of residual<br>or powder on finished powder-<br>free gloves as < 2 mg per glove<br>and there is no defect glove<br>found according to ASTM<br>D6124-06. | According to ASTM<br>D6124-06 Standard Test<br>Method for Residual<br>Powder on Medical<br>gloves for the<br>determination of residual<br>powder content. Testing<br>result indicates the weight<br>of all types of residual or<br>powder on finished<br>powder-free gloves as < 2<br>mg per glove and there is<br>no defect glove found<br>according to ASTM<br>D6124-06. | Similar |
| Pinhole Results | According to ASTM D5151-<br>06, Testing result indicates<br>pinhole were found less than | According to ASTM<br>D5151-06, Testing result<br>indicates pinhole were<br>found less than two pieces | Similar |
| | two pieces gloves out of 125<br>pieces gloves. AQL 2.5 is met. | gloves out of 125 pieces<br>gloves. AQL 2.5 is met. | |
| Biocompatibility<br>Result: Primary<br>Skin Irritation | Under the conditions of the<br>study, the subject device is not<br>an irritant | Under the conditions of<br>the study, the subject<br>device is not an irritant | Similar |
| Before Aging:<br>Tensile<br>Strength(Mpa) and<br>Ultimate<br>Elongations | Average Tensile Strength<br>(Mpa): 16.96<br>Average Ultimate Elongations:<br>519% | Average Tensile Strength<br>(Mpa): 16.96<br>Average<br>Ultimate<br>Elongations: 519% | Similar |
| After Aging:<br>Tensile<br>Strength(Mpa) and<br>Ultimate<br>Elongations | Average Tensile Strength<br>(Mpa): 14.92<br>Average Ultimate Elongations:<br>480% | Average Tensile Strength<br>(Mpa): 14.92<br>Average<br>Ultimate<br>Elongations: 480% | Similar |
| Dermal<br>Sensitization | Under the conditions of the<br>study, the subject device is not<br>an sensitizer | Under the conditions of<br>the study, the subject<br>device is not an sensitizer | Similar |
| Summary | Shandong Zhi Hong Medical Products, Co. Ltd. Clear Vinyl Powder-free<br>Patient Examination Gloves are Similar to the predicate, K142703. Both gloves<br>have the same intended use, same material and the same device performance. | | |

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Shandong Zhi Hong Medical Products, Co. Ltd.

#### 231 Dongqi Industrial Park Qingzhou City, Shandong China

## Conclusion

The conclusions drawn from the nonclinical and clinical tests that demonstrate that the subject device is as safe, as effective, and performs as well as the predict device.