Powder-free Clear Vinyl Patient Examination Gloves

K173078 · Yongsheng Medical Products Co., Ltd. · LYZ · Mar 9, 2018 · General Hospital

Device Facts

• Record ID: K173078
• Device Name: Powder-free Clear Vinyl Patient Examination Gloves
• Applicant: Yongsheng Medical Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Mar 9, 2018
• 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 vinyl patient examination glove; worn by clinicians to prevent cross-contamination between patient and examiner. Device acts as a physical barrier. Used in clinical settings. No electronic components or software.

Clinical Evidence

No clinical data. Bench testing only, including physical property testing (tensile strength, elongation), pinhole testing (ASTM D5151-06), residual powder testing (ASTM D6124-06), and biocompatibility studies (primary skin irritation and dermal sensitization).

Technological Characteristics

Material: Vinyl. Standards: ASTM D5250-06, ASTM D6124-06 (residual powder), ASTM D5151-06 (pinhole). Form factor: Disposable glove. No energy source, connectivity, or software.

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 PVC Vinyl Exam Gloves Hebei Grandeast Plastic Products Co.,Ltd. (K142703)

Submission Summary (Full Text)

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March 9, 2018

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

Re: K173078

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: January 29, 2018 Received: February 2, 2018

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 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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K173078

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

# Michael J. Ryan -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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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

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

510(k) Number (if known)

K173078

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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FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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#### 510(k) SUMMARY K173078

- 1. Submitter's Identification:
Yongsheng Medical Products Co., Ltd No. 4519 Qingzhou Road Shao De Industrial Park China Contact Person: Melo Zhang Official Correspondent

Date summary prepared: March 6, 2018

- 2. Name of the Device:
Yongsheng Medical Products Co., Ltd Powder-free Clear Vinyl Patient Examination Gloves

- 3. Trade Name
Yongsheng Medical Products Co., Ltd Powder-free Clear Vinyl Patient Examination Gloves

- 4. Predicate Device Information:
Powder-free PVC Vinyl Exam Gloves Hebei Grandeast Plastic Products Co.,Ltd. K 142703

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#### 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 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, LYZ, and meets all requirement of ASTM Standard 5250-06.

- 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.

- 7. Technological Characteristic Comparison:

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| Device<br>Characteristics | Proposed Device | Predict Device<br>(K142703) | Comparison<br>Conclusion |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Product Name | Yongsheng Medical Products<br>Co., Ltd<br>Powder-free Clear Vinyl<br>Patient Examination Gloves | Hebei Grandeast Plastic<br>Products Co., Ltd.<br>Glide-On Vinyl<br>Examination Gloves | Similar |
| Product Code | LYZ | LYZ | Similar |
| Intended Use | Disposable device intended<br>for medical purposes that is<br>worn on the examiner's hand<br>or finger to prevent<br>contamination between<br>patient and examiner | Disposable device intended for<br>medical purposes that is worn<br>on the examiner's hand or<br>finger to prevent contamination<br>between patient and examiner | Similar |
| Length on Large<br>Size | Average over 232.23mm | >230 mm | Similar |
| Width of Palm on<br>Large Size | Average 95mm | >105 mm | Similar |
| Palm Thickness | Average 0.095 mm | 0.10 mm | Similar |
| Fingertip<br>Thickness | Average 0.09 mm | 0.10 mm | Similar |
| Residual Powder | According to ASTM D6124-<br>06 Standard Test Method for<br>Residual Powder on Medical<br>gloves for the determination<br>of residual powder content.<br>Testing result indicates the<br>weight of all types of residual<br>or powder on finished<br>powder-free gloves as < 2 mg<br>per glove and there is no<br>defect glove found according<br>to ASTM D6124-06. | < 2 mg per glove | Similar |
| Pinhole Results | According to ASTM D5151-<br>06, Testing result indicates<br>pinhole were found less than<br>two pieces gloves out of 125<br>gloves. AQL 2.5 is met. | Comply with ASTM D5151-06,<br>Testing result indicates pinhole<br>were found less than two pieces<br>gloves out of 200 gloves. AQL<br>2.5 is met. | Similar |

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

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| Biocompatibility<br>Result: Primary<br>Skin Irritation | Under the conditions of the<br>study, the subject device is<br>not an irritant | Under the conditions of the<br>study, the subject device is not<br>an irritant | Similar |
|---------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|---------|
| Before Aging:<br>Tensile Strength<br>(Mpa) and<br>Ultimate<br>Elongations | Average Tensile Strength<br>(Mpa): 17.4<br>Average Ultimate<br>Elongations: 519% | Average Tensile Strength<br>(Mpa): 11<br>Average Ultimate Elongation:<br>>300% | Similar |
| After Aging:<br>Tensile Strength<br>(Mpa) and<br>Ultimate<br>Elongations | Average Tensile Strength<br>(Mpa): 14.96<br>Average Ultimate<br>Elongations:480.76% | Average Tensile Strength<br>(Mpa): 11<br>Average Ultimate Elongation<br>>300% | Similar |
| Dermal<br>Sensitization | Under the conditions of the<br>study, the subject device is<br>not a sensitizer | Under the conditions of the<br>study, the subject device is not<br>a sensitizer | Similar |
| Summary | Yongsheng Medical Products Co., Ltd Powder-free Clear Vinyl Patient<br>Examination Gloves are similar to the predicate, K142703. | | |

- 8. Discussion of Non-Clinical tests performed for Determination of Substantial Equivalence are as follows:
The standards used for Yongsheng Medical Products Co., Ltd glove production is based on ASTM-D5250-06. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 2.5.

The 1000ml. 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.

Our gloves meet our "powder-free" claims and contain no more than 2 mg powder per glove.

- 9. Conclusions:
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.