Powder-free PVC Vinyl Exam Gloves

K142703 · Hebei Grandeast Plastic Products Co., Ltd. · LYZ · Jan 15, 2015 · General Hospital

Device Facts

• Record ID: K142703
• Device Name: Powder-free PVC Vinyl Exam Gloves
• Applicant: Hebei Grandeast Plastic Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Jan 15, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Powder-free PVC Vinyl Exam Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

Device Story

Disposable, non-sterile, non-colored PVC vinyl examination gloves; worn on examiner's hands or fingers; function as physical barrier to prevent cross-contamination between patient and examiner; used in clinical settings; single-use; no electronic or software components.

Clinical Evidence

Bench testing only. No clinical data. Compliance verified via ASTM D5250-06, ASTM D5151-06, ASTM D6124-06, and ISO 10993-10 for irritation and sensitization.

Technological Characteristics

Material: Poly(Vinyl Chloride) (PVC) with Polyurethane (PU) lubricant. Form factor: Disposable gloves in sizes S, M, L, XL. Standards: ASTM D5250-06, ASTM D5151-06, ASTM D6124-06, ISO 10993-10. Non-sterile. No electronic components 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

• Benteng Power Free Vinyl Patient Examination Gloves, Clear (non-colored) (K130733)

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

January 15, 2015

Hebei Grandeast Plastic Products Co., Ltd. C/O Ms. Diana Hong General Manager Mid- Link Consulting Co., Ltd. PO Box 120-119, Shanghai CHINA

Re: K142703

Trade/Device Name: Powder-Free PVC Vinyl Patient Examination Gloves, Clear (non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient examination glove Regulatory Class: I Product Code: LYZ Dated: December 15, 2014 Received: December 19, 2014

Dear Ms. Diana Hong:

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.

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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 device-related 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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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,

*Tejashri Purohit-Sheth, M.D.*

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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)

K142703

Device Name

Powder-free PVC Vinyl Exam Gloves

Indications for Use (Describe)

The Powder-free PVC Vinyl Exam Gloves are disposable devices intended for medical purposes that are worn on 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)

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

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# Tab #2 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: __________________________________________________________________________________________________________________________________________________

- 1. Date of Submission: 01/06/2015
- 2. Sponsor Identification

Hebei Grandeast Plastic Products Co., Ltd. Industrial Park, Julu County, Hebei Province, China

Establishment Registration Number: Not yet registered

Contact Person: Wei Liu Position: Sale Manager Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Submission Correspondent
Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: [phone] Fax: [phone] Email: [e-mail]

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- 4. Proposed Device Identification
Proposed Device Name: Powder-free PVC Vinyl Exam Gloves Proposed Device Common Name: Powder-free Exam Gloves

Regulatory Information: Classification Name: Vinyl Patient Examination Glove: Classification: I; Product Code: LYZ; Regulation Number: 21 CFR 880.6250; Review Panel: General Hospital;

Intended Use Statement:

The Powder-free PVC Vinyl Exam Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

- 5. Predicate Device Identification
510(k) Number: K130733

Product Name: Benteng Power Free Vinyl Patient Examination Gloves, Clear (non-colored) Manufacturer: Benteng Plastic Co., Ltd.

- Device Description 6.
The proposed devices, Powder-free PVC Vinyl Exam Gloves are non-sterile, non-colored and disposable medical gloves intended to be worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

- 7. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ASTM D5250-06 (Reapproved 2011), Standard Specification For Poly(Vinyl Chloride) Gloves For Medical Application.

ASTM D5151-06 (Reapproved 2011), Standard Test Method For Detection Of Holes In Medical Gloves. ASTM D6124-06 (Reaffirmation 2011), Standard Test Method For Residual Powder On Medical Gloves.

ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin

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sensitization.

- 8. Substantially Equivalent (SE) Conclusion
The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.

| Item | Proposed Device(s) | Predicate Device(s) |
|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LYZ | LYZ |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 |
| Class | I | I |
| Intended Use | The Powder-free PVC Vinyl Exam<br>Gloves are disposable devices intended<br>for medical purposes that are worn on<br>the examiner's hands or fingers to<br>prevent contamination between patient<br>and examiner. | Powder Free Vinyl Patient<br>Examination Gloves, Clear<br>(non-colored) is non-sterile disposable<br>device intended for medical purposes<br>that is worn on the examiner's hand or<br>finger to prevent contamination<br>between patient and examiner. |
| Powdered or<br>Powered free | Powered free | Powered free |
| Size | S, M, L and XL | S, M, L and XL |
| Dimensions<br>Length | Comply with ASTM D5250-06<br>(Reapproved 2011)<br>> 230 mm | Comply with ASTM D5250-06<br>(Reapproved 2011)<br>> 230 mm |
| Dimensions<br>Width | Comply with ASTM D5250-06<br>(Reapproved 2011)<br>S 85±5mm<br>M 95±5mm<br>L 105±5mm<br>XL 115±5mm | Comply with ASTM D5250-06<br>(Reapproved 2011)<br>S 85±5mm<br>M 95±5mm<br>L 105±5mm<br>XL 115±5mm |
| Dimensions<br>Thickness | Comply with ASTM D5250-06<br>(Reapproved 2011)<br>Palm 0.10±0.02mm<br>Finger-tip 0.10±0.02mm | Comply with ASTM D5250-06<br>(Reapproved 2011)<br>Palm > 0.08mm<br>Finger-tip > 0.05mm |
| Colorant | No colorant used | No colorant used |
| Single Use | Yes | Yes |
| Physical<br>Properties | Before aging / after aging:<br>Tensile Strength ≥ 11Mpa. | Before aging / after aging:<br>Tensile Strength ≥ 11Mpa. |
| | | |
| | Ultimate Elongation $\ge$ 300%<br>Comply with ASTM D5250-06<br>(Reapproved 2011) | Ultimate Elongation $\ge$ 300%<br>Comply with ASTM D5250-06<br>(Reapproved 2011) |
| Freedom from<br>Holes | Comply with ASTM D5250-06<br>(Reapproved 2011) and ASTM<br>D5151-06 (Reapproved 2011) | Comply with ASTM D5250-06<br>(Reapproved 2011) and ASTM<br>D5151-06 (Reapproved 2011) |
| Residue Powder | 0.6 +/- 0.1 mg per glove<br>Comply with ASTM D5250-06<br>(Reapproved 2011) | $<$ 2mg per glove<br>Comply with ASTM D5250-06<br>(Reapproved 2011) |
| Compare<br>performance data<br>supporting<br>substantial<br>equivalence | Comply with<br>ASTM D5250-06 (Reapproved 2011),<br>ASTM D5151-06 (Reapproved 2011),<br>ASTM D6124-06 (Reaffirmation 2011) | Comply with<br>ASTM D5250-06 (Reapproved 2011),<br>ASTM D5151-06 (Reapproved 2011),<br>ASTM D6124-06 (Reaffirmation 2011) |
| Material | Main material: PVC<br>Lubricant: PU | Main material: PVC<br>Lubricant: PU |
| Biocompatibility | Sensitization | Under the conditions of<br>this study, not a<br>sensitizer |
| | Irritation | Under the conditions of<br>this study, not an<br>irritant |
| | | Comply with ISO 10993-10 |
| Sterilization | Non-sterile | Non-sterile |
| Label and<br>Labeling | | |
| | | GuardFlex Powder Free PVC Vinyl<br>Exam Gloves<br>non sterile<br>single use only<br>Manufacturer and address<br>Lot No.<br>Avoid excessive heat<br>This product is latex free<br>Size, Quantity, Manufacture Date,<br>Indications for Use |
| | | power free,<br>patient examination glove<br>devices color: clear (non-colored)<br>non sterile<br>single use only<br>manufactured for<br>lot |
| | | |
| | | |
| | | |
| | | |
| | | |

Table 1 Comparison of Technology Characteristics

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The proposed devices, Powder-free PVC Vinyl Exam Gloves are determined to be Substantially Equivalent (SE) to the predicate devices, Benteng Power Free Vinyl Patient Examination Gloves, Clear (non-colored) (K130733), in respect of safety and effectiveness.