Powder-free Clear Vinyl Patient Examination Gloves

K171460 · Shandong Zhiwei Medical Products, Co. , Ltd. · LYZ · Sep 24, 2017 · General Hospital

Device Facts

• Record ID: K171460
• Device Name: Powder-free Clear Vinyl Patient Examination Gloves
• Applicant: Shandong Zhiwei Medical Products, Co. , Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Sep 24, 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 upon the examiner's hands or fingers to prevent contamination between patient and examiner.

Device Story

Disposable, non-sterile, powder-free vinyl patient examination glove; worn by healthcare examiners to provide a barrier against contamination between patient and examiner. Device consists of polyvinyl chloride (PVC) material shaped as a hand/wrist garment with individual finger/thumb sheaths. Used in clinical settings; operated by healthcare personnel. Provides physical barrier protection; reduces risk of cross-contamination. Benefits patient and examiner by maintaining hygiene standards during examinations.

Clinical Evidence

Bench testing only. Testing included physical dimensions, tensile strength (before/after aging), residual powder content (<2mg/glove), pinhole leak testing (AQL 2.5), and biocompatibility (primary skin irritation and dermal sensitization). All results met ASTM D5250-06 requirements.

Technological Characteristics

Material: Polyvinyl Chloride (PVC). Form factor: Disposable, non-sterile, powder-free glove. Standards: ASTM D5250-06 (physical/dimensions), ASTM D6124-06 (residual powder), ASTM D5151-06 (pinholes). Residual powder < 2mg/glove. Tensile strength: 16.96 MPa (before aging), 14.92 MPa (after aging). Elongation: 519% (before aging), 480% (after aging).

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hands or fingers 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 Vinyl Examination Gloves (K100699)
• Powder Free Vinyl Patient Examination Gloves (K022091)

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 24, 2017

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

Re: K171460

Trade/Device Name: Powder-free Clear Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: July 28, 2017 Received: May 18, 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 or any Federal statutes and regulations administered by other Federal agencies. You must comply

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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 (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 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 2017.09.24 19:33:34 -04'00'

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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## Indications for Use

510(k) Number (if known) K171460

Device Name

Powder-free Clear Vinyl Patient Examination Gloves

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)

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

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

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# 510 (K) SUMMARY

#### 1. Submitter's Identification:

Shandong Zhiwei Medical Products Co., Ltd. No. 4519 Oingzhou Road Shao De Industrial Park China Contact Person: Melo Zhang Official Correspondent

Date summary prepared: September 13, 2017

#### 2. Name of the Device:

Shandong Zhiwei Medical Products Co., Ltd. Powder-free Clear Vinyl Patient Examination Gloves Classification Name: Patient Examination Glove Product Code: LYZ Product Class: Class I Regulation #: 21 CFR 880.6250 Classification Panel: General Hospital

#### 3. Trade Name

Shandong Zhiwei Medical Products Co., Ltd. Powder-free Clear Vinyl Patient Examination Gloves

#### 4. Predicate Device Information:

Shijiazhuang Star Plastic Co., Ltd. Powder Free Vinyl Examination Gloves - (K100699)

Tangshan Zhonghong Pulin Food Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves - (K022091)

#### 5. Device Description:

A Powder-free Clear Vinyl Patient Examination Gloves 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). Our Powder-free Clear Vinyl Patient Examination Gloves do not contain any UPS powder according to the results of testing conducted on the gloves. The residual powder

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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, 80LYZ, and meets all requirement of ASTM Standard D5250-06.

#### 6. Indication 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)

#### 7. Comparison to Predicate Devices:

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

| | Proposed Device<br>(K171460) | Predicate Device<br>(K022091) | Predicate Device<br>(K100699) | | | |
|--------------------------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|---------------------|------------------------|------------------------|
| Description | Shandong Zhiwei Medical<br>Products Co., Ltd. Powder-free<br>Clear Vinyl Patient Examination<br>Gloves | Tangshan<br>Zhonghong Pulin<br>Food Products Co.,<br>Ltd Class I vinyl<br>patient examination<br>gloves, powder-free | Shijiazhuang Star<br>Plastic Co., Ltd<br>Powder Free Vinyl<br>Patient<br>Examination<br>Gloves | | | |
| | Indication for<br>Use | Disposable device intended for<br>medical purposes that is worn on<br>the examiner's hand or finger to<br>prevent contamination between<br>patient and examiner | similar | similar | | |
| | | Basic Design | A garment covering the hand and<br>wrist area. Clovers have separate<br>sheaths or openings for each finger<br>and the thumb. | similar | similar | |
| | | | Materials Used | Poly Vinyl Chloride | Poly Vinyl<br>Chloride | Poly Vinyl<br>Chloride |
| | | | Single Use | Yes | Yes | Yes |
| | | Sterile | Not sterile | Not sterile | Not sterile | |
| Length on Large<br>Size | Average over 231.62mm | Similar | Similar | | | |
| Width of Palm<br>on Large Size | Average 95mm | Similar | Similar | | | |
| Palm Thickness | Average 0.095 mm | Similar | Similar | | | |
| Fingertip<br>Thickness | Average 0.09 mm | Similar | Similar | | | |
| Residual Powder | According to ASTM D6124-06<br>Standard Test Method for Residual | Similar | Similar | | | |

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| | Powder on Medical gloves for the<br>determination of residual powder<br>content. Testing result indicates<br>the weight of all types of residual<br>or powder on finished powder-free<br>gloves as < 2 mg per glove and<br>there is no defect glove found<br>according to ASTM D6124-06. | | |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------|
| Pinhole Results | According to ASTM D5151-06,<br>Testing result indicates pinhole<br>were found less than two pieces<br>gloves out of 125 pieces gloves.<br>AQL 2.5 is met. | Similar | Similar |
| Before Aging:<br>Tensile<br>Strength(Mpa)<br>and Ultimate<br>Elongations | Average Tensile Strength (Mpa):<br>16.96<br>Average Ultimate Elongations:<br>519% | Similar | Similar |
| After Aging:<br>Tensile<br>Strength(Mpa)<br>and Ultimate<br>Elongations | Average Tensile Strength (Mpa):<br>14.92<br>Average Ultimate Elongations:<br>480% | Similar | Similar |
| Biocompatibility<br>Result: Primary<br>Skin Irritation | Under the conditions of the study,<br>the subject device is not an irritant | Similar | Similar |
| Dermal<br>Sensitization | Under the conditions of the study,<br>the subject device is not an<br>sensitizer | Similar | Similar |

### Discussion of Non-Clinical tests performed for Determination of Substantial 8. Equivalence are as follows:

The standards used for Shandong Zhiwei Medical Products Co., Ltd. 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, AQL 2.5.

The FDA 1000 ml. Water Fill Test was also conducted with samplings of AOL 2.5, Inspection Level I, meeting these requirements, Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.

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There are no special labeling claims and we do not claim our gloves as hypoallergenic is conducted to insure our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove).

#### 9. Conclusion:

Shandong Zhiwei Medical Products Co., Ltd. Powder-free Clear Vinyl Patient Examination Gloves is as safe, as effective and is demonstrated to be substantially equivalent to the predicate device.