POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE

K131440 · Hebei Hongsen Plastics Technology Co, Ltd. · LZA · Sep 25, 2013 · General Hospital

Device Facts

• Record ID: K131440
• Device Name: POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
• Applicant: Hebei Hongsen Plastics Technology Co, Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Sep 25, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Titans powder free nitrile patient examination glove, blue color, 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. It has blue color and is sold as non sterile.

Device Story

Disposable, non-sterile, blue-colored patient examination glove; manufactured from synthetic nitrile rubber. Worn by healthcare examiners on hands or fingers to provide a protective barrier against contamination between patient and examiner. Single-use design; available in sizes XS through XXL. Device functions as a physical barrier; no electronic or mechanical components. Used in clinical or medical settings by healthcare professionals.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including physical dimensions, physical properties (tensile strength/elongation), pinhole leak testing (ASTM D5151), powder residue (ASTM D6124), and biocompatibility (ISO 10993-10 primary skin irritation and dermal sensitization).

Technological Characteristics

Material: Synthetic nitrile rubber. Form factor: Hand-shaped glove with separate finger/thumb sheaths. Standards: ASTM D6319-10 (dimensions/physical properties), ASTM D5151 (pinholes), ASTM D6124 (powder residue), ISO 10993-10 (biocompatibility). Non-sterile. Single-use.

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. Suitable for general patient examination settings.

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

• Patient Nitrile Examination Gloves, Powder Free, Non-Sterile, Blue (1) Color (K121992)

Submission Summary (Full Text)

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Section 5: 510k Summary

# Section 5: 510(k) Summary:

This summary of 510k safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92

#### Submitter & Foreign Manufacture Identification 5.1

Hebei HongSen Plastics Technology Co., Ltd The Eastern Industrial Accumulation Area Nangong City, Xingtai City, Hebei Province, China Tel: [phone] Submitter's FDA Registration Number: N/A

SEP 2 5 2013

#### 5.2 US Agent and Contact Person

Charles Shen Manton Business and Technology Services 5 Carey Street Pennington, NJ 08534 Tel: [phone] Email: [e-mail]

#### Date of Summary: April 15, 2013 5.3

5.4 Device Name: Proprietary Name:

Common Name: Classification Name: Device Classification: Regulation Number: Panel: General Product Code:

Powder Free Patient Examination Gloves, Blue Color (Brand Name: Titans) Patient examination glove Patient examination glove I 21 CFR 880.6250 Hospital LZA

#### Predicate Device Information: ર્ડ

:

K121992, "Patient Nitrile Examination Gloves, Powder Free, Non-Sterile, Blue (1) Color", manufactured by "Xinwei (Shandong) Plastic and Rubber Products Co., Ltd."

#### ર્સ્વર્સ Device description:

Powder free nitrile examination gloves are made of synthetic nitrile rubber, and are non sterile that meets all of the requirements of ASTM standard D 6319-10, except for sterility requirements. They have blue color.

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#### 5.7 Intended Use:

The Titans powder free nitrile patient examination glove, blue color, 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. It has blue color and is sold as non sterile.

#### 5.8 Comparison to Predicate Devices

The powder free nitrile examination gloves, blue, non sterile are compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance.

K121992, "Patient Nitrile Examination Gloves, Powder Free, Non-Sterile, Blue (1) Color", manufactured by "Xinwei (Shandong) Plastic and Rubber Products Co., Ltd."

The following table shows similarities and differences of use, design, and material between our device and the predicate devices.

| Description | Our Device | Predicate Device (K121992) |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for<br>Use | Disposable device intended for medical<br>purposes that is worn on the examiner's hand<br>or finger to prevent contamination between<br>patient and examiner. It has blue color and is<br>sold as non sterile. | A patient examination glove is a<br>disposable device intended for<br>medical purposes that is<br>worn upon the examiner's hands or<br>finger to prevent contamination<br>between patient and examiner<br>(2ICFR 880.6250) |
| Basic Design | A garment covering the hand and waist<br>area. Gloves have separate sheaths or<br>openings for each finger and the thumb. | Same |
| Materials | Nitrile rubber | Same |
| Size | XS, S, M, L, XL, XXL | S, M, L,XL |
| Single Use | Yes | Yes |
| Color | blue | Blue |
| Sterile | Non sterile | None Sterile |

# Table 5.1: Comparison of Intended Use, Design, and Material

Our device is essentially identical to the predicate device in terms of indications for use, design, and material between our device and the predicate devices.

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Section 5: 510k Summary

The following table shows similarities and differences of the performance between our device and the predicate devices. Tests were conducted following the recommended procedures outlined in the respective consensus standards, and results for Powder Free Patient Examination Gloves, Blue Color (Brand Name: Titans), manufactured by "Hebei HongSen Plastics Technology Co., Ltd. " met all relevant requirements in the test standards, and are comparable to the predicate device.

| Description | Our Device | Predicate Device (K121992) |
|-------------------------------------------------|------------------------------------------------------------------|----------------------------------------------------|
| Dimension | Meets ASTM D 6319-10<br>(Published 03/18/2011) | Meets ASTM D 6319-10<br>(Publication date unknown) |
| Physical Property | Meets ASTM D 6319-10<br>(Published 03/18/2011) | Meets ASTM D 6319-10<br>(Publication date unknown) |
| Free of Pinhole | Meets ASTM D5151 (AQL<br>2.5)<br>(Published 08/20/2012) | Meets ASTM D5151<br>(Publication date unknown) |
| Residue Powder | Meets ASTM D6124<br>(Published 08/20/2012) | Meets ASTM D6124<br>(Publication date unknown) |
| Primary Skin Irritation<br>(ISO 10993-10: 2010) | Not a primary skin irritant under<br>the conditions of the study | Same |
| Dermal sensitization<br>(ISO 10993-10: 2010) | Not a dermal sensitizer under the<br>conditions of the study | Same |

| Table 5.2: Comparison of Physical, Biocompatibility and Performance Testing | | | |
|-----------------------------------------------------------------------------|--|--|--|
| | | | |

A brief discussion of the non-clinical testing data that was submitted, 5.9 referenced or relied on to demonstrate that the Subject Device is safe and effective, and whose performance meets the requirements of its user-defined acceptance criteria and intended uses:

Powder Free Patient Examination Gloves, Blue Color (Brand Name: Titans) meet requirements per ASTM D6319-10, ASTM D6124-06, ASTM D 5151-06, and ISO 10993-10. It is safe and effective, and its performance meets the requirements of its predefined acceptance criteria and intended uses.

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### A brief discussion of the clinical submitted, reference, or relied on in the 5.10 premarket notification submission for a determination of substantial equivalence.

Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

#### Substantial Equivalent Conclusions 5.11

Based on the comparison of intended use, design, materials, and performance, our Powder Free Patient Examination Gloves, Blue Color (Brand Name: Titans) are substantial equivalent to its predicate devices.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

## September 25, 2013

Hebei HongSen Plastics Technology Company Limited C/O Charles Shen Manton Business and Technology Services 5 Carey Street PENNINGTON NJ 08534 US

- Re: K131440
Trade/Device Name: Powder Free Nitrile Patient Examination Gloves, Blue Color (Brand Name Titans) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: July 11, 2013 Received: July 1, 2013

Dear Mr. Shen:

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

FDA Richard C.
Chapman

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

for

Enclosure

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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K131440

## Device Name

Powder Free Nitrile Patient Examination Gloves, Blue color (Brand Name: Titans)

## Indications for Use (Describe)

The Titan powder free nitrile patient examination glove, blue color, 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. It has blue color and is sold as non sterile.

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

[ Prescription Use (Part 21 CFR 801 Subpart D)

> Over-The-Counter Use (21 CFR 807 Subpart C)

EF

PSC | | | shindang Services (301) | 443-6740

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Concurrence

FORM FDA 3881 (6/13)

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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# Elizabeth F. Claverie 2013.09.25 14:04:24