POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

K102977 · Heze Juxinyuan Food Co., Ltd. · LYZ · Dec 20, 2010 · General Hospital

Device Facts

• Record ID: K102977
• Device Name: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
• Applicant: Heze Juxinyuan Food Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Dec 20, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile 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

Disposable, non-sterile vinyl patient examination gloves; worn on examiner's hands or fingers. Primary function is barrier protection to prevent cross-contamination between patient and examiner during medical procedures. Used in clinical or general hospital settings. No complex electronics, software, or algorithms involved.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing, including physical property testing, water leak tests for pinholes, and biocompatibility testing (ISO 10993-10).

Technological Characteristics

Material: Vinyl. Non-sterile. Standards: ASTM D5250-06e1 (dimensions, physical properties, powder residual), ASTM D6124-06 (powder residual), 21 CFR 800.20 (pinholes), ISO 10993-10 (biocompatibility). Powder residual <2mg/glove.

Indications for Use

Indicated for use as a non-sterile, disposable patient examination glove worn by examiners to prevent cross-contamination between patient and examiner. Suitable for over-the-counter use.

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

• FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves (K032908)

Submission Summary (Full Text)

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# Section C 510(k) Summary (21 CFR 807.92)

DEC 2 0 2010

# 510(K) Summary

"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."

"The assigned 510(k) number is: 1029177 " (applicant leave blank)

Premarket Notification [510(k)] Summary

#### [(a)(1)]. The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared :

| Submitter's name : | Heze Juxinyuan Food Co.,Ltd. | |
|--------------------------------|-------------------------------------------------------------------------------|--|
| Submitter's address : | Jinzhuang Zone, Suji, Caoxian , Heze City,<br>Shandong Province, 274415,China | |
| Phone number : | 0086-530-5022111 | |
| Fax number : | 0086-530-5311988 | |
| Name of contact person: | Mr. Wenzhong Zhang | |
| Date the summary was prepared: | Sep.19, 2010 | |

#### [(a)(2)]. The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known

| Device Name: | Powder Free Vinyl Patient Examination Gloves,<br>Clear (non-colored) |
|-------------------------|--------------------------------------------------------------------------------------------------------|
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination Gloves,<br>Clear (non-colored)<br>Other clients private labeling |
| Common Name: | Exam gloves |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital<br>(80) |
| Product Code: | LYZ |

## [(a)(3)]. An identification of the legally marketed device to which your firm is claiming substantial equivalence .

Class I* Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.

### Section C

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Predicate device: FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032908 .

#### [(a)(4)] A description of the device

Device Description: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.

#### [(a)(5)] The summary describes the intended use of the device

Device Intended Use: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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)(6)] A summary of the technological characteristics of new device compared to the predicate device.

The Powder Free Vinyl Patient Examination Gloves, Clear (non-colored), non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.

| Characteristics | Standard | Device performance |
|-----------------------|--------------------------------------------------------|-----------------------------------------|
| Dimension | ASTM standard D 5250-06 e1. | Meets |
| Physical Properties | ASTM standard D 5250-06 e1. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 e1<br>and D6124-06 | Meets<br><2mg/glove |
| Biocompatability | Primary Skin Irritation in rabbits<br>ISO 10993-10 | Passes<br>Not a Primary Skin Irritation |
| | Dermal sensitization in the guinea pig<br>ISO 10993-10 | Passes<br>Not a Dermal sensitization |

#### [(b)(1)] A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored), meet requirements per ASTM D5250-06 el, per ASTM D6124-06, per 21 CFR 800.20 and FDA recognition number 2-87: ISO 10993-10:2002.

#### [(b)(2)] A brief discussion of the clinical submitted, reference, or relied on in the 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.

### [(b)(3)] The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performed as well or better than the legally marketed device identified in (a)(3).

It can be concluded that the Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims.

It can be concluded that the Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is as safe, as effective, and performs as well as the predicate device, FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032908

#### Section C

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Heze Juxinyuan Food Company, Limited C/O Mr. Chu Xiaoan Beijing Easy-Link Company, Limited Room 1606 Building 1 Jian Xiang Yuan N209 Bei Si Huan Beijing China 100083

DEC 2 0 2010

Re: K102977

Trade/Device Name: Powder Free 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: September 27, 2010 Received: October 6, 2010

Dear Mr. Xiaoan:

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

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# Page 2- Mr. Xiaoan

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

Jacus J. Robertson
for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices

Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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#### DEC 2 0 2010 INDICATIONS FOR USE

Heze Juxinyuan Food Co.,Ltd. Applicant:

## 510(k) Number (if known): * 1029 77

Device Name: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

#### Indications For Use:

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Edith S. (Clemis-Will

(Division Sign-Off)
(Division Sign-Off)
Division of Anesthesinlogy, General Hospital
Provision of Anesthesinlogy, General Devices Division of Antoonomics Infection Control Devices

510(k) Number: K102977