LEGEND (BRAND) NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE

K030529 · Jda (Tianjin) Plastic Rubber Co., Ltd. · LZA · Aug 8, 2003 · General Hospital

Device Facts

• Record ID: K030529
• Device Name: LEGEND (BRAND) NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE
• Applicant: Jda (Tianjin) Plastic Rubber Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Aug 8, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Nitrile powder-free 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.

Device Story

Disposable nitrile patient examination glove; worn on examiner's hand or finger; serves as barrier to prevent contamination between patient and examiner. Used in clinical settings by healthcare professionals. Device provides physical protection; manufactured to meet ASTM D6319-00ae3 standards for dimensions, physical properties, and powder residuals. Benefit includes reduction of cross-contamination risk during medical examinations.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance demonstrated via ASTM D6319-00ae3 (dimensions, physical properties), ASTM D6124-01 (powder residual), 21 CFR 800.20 (pinholes), and ISO 10993-10 (biocompatibility/irritation/sensitization).

Technological Characteristics

Nitrile rubber; powder-free; non-sterile. Meets ASTM D6319-00ae3 for dimensions and physical properties (tensile strength, elongation). Biocompatibility per ISO 10993-10. Pinhole testing per 21 CFR 800.20. Powder residual <2mg/glove per ASTM D6124-01.

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.

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

• Nitrile powder-free patient examination glove, JDA International Inc. (K993247)

Submission Summary (Full Text)

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# AUG = 8 2003

## C 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 "

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

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 : | JDA (TIANJIN) PLASTIC RUBBER CO., LTD. |
|--------------------------------|-----------------------------------------------------------------------|
| Submitter's address : | 17 HAIBIN 7 RD. TIANJIN TREE TRADE ZONE,<br>TIANJIN ,300456,P.R.China |
| Phone number : | (86)22-25760468 |
| Fax number : | (86)22-25760466 |
| Name of contact person: | Wan Dong Hua, Technology Department Manager |
| Date the summary was prepared: | 23 May 2003 |

#### [(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 | Nitrile powder-free patient examination glove |
|-------------------------|-------------------------------------------------------------|
| Proprietary/Trade name: | LEGEND™ Nitrile powder-free patient examination glove |
| Common Name: | Other clients private labeling<br>Patient examination glove |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LZA |

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

Class I* Nitrile powder-free patient examination, that meets all of the requirements of ASTM standard D 6319-00ae3.

Predicate device : Nitrile powder-free patient examination glove, JDA International Inc. k993247 .

#### |(a)(4)| A description of the device

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K030529

Device Description : Nitrile powder-free patient examination, that meets all of the requirements of ASTM standard D 6319-00ae3.

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

Device Intended Use: Nitrile powder-free 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)(6)] A summary of the technological characteristics of new device compared to the predicate device.

The nitrile powder-free patient examination glove, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.

| Characteristics | Standard | Device performance |
|-----------------------|-------------------------------------------|-----------------------------------------|
| Dimension | ASTM standard D 6319-00ae3. | Meets |
| Physical Properties | ASTM standard D 6319-00ae3. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 6124-01 | Meets<br><2mg/glove |
| Biocompatability | Primary Skin Irritation in rabbits | Passes<br>Not a Primary Skin Irritation |
| | Dermal sensitization in the guinea<br>pig | 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 .

Nitrile powder-free patient examination glove meet requirements per ASTM D6319-00ac3, per ASTM D6124-01, per 21 CFR 800.20 and ISO10993-10.

#### [(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 LEGEND™ Nitrile powder-free patient examination gloves meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims .

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#### Appendix 2.0 Product specification

The Nitrile powder-free patient examination glove meet ALL the current specifications listed under the ASTM Specification D 6319-00ae3.

- 1. Dimension

| | | (mm) |
|------------|------------------|---------------|
| DEMENTION | ASTM D6319-00ae3 | LEGEND'S |
| Palm Width | | |
| Small | $80+/-10$ | 80-90 |
| Medium | $95 +/-10$ | 90-100 |
| Large | $110 +/-10$ | 100-110 |
| X-Large | $120 +/-10$ | 110-120 |
| Length | | |
| Small | 220 min | 240-250 |
| Medium | 230 min | for all sizes |
| Large | 230 min | for all sizes |
| X-Large | 230 min | for all sizes |
| Thickness | | |
| finger | 0.05 min | $0.12+/-0.01$ |
| palm | 0.05 min | $0.12+/-0.01$ |

## 2. Physical properties

| (mm) | | | | |
|---------------------------------------------------------------------|------------------------|----------|------------------------|----------|
| | Tensile strength (MPa) | | Ultimate elongation(%) | |
| | ASTM<br>D6319-00ae3 | LEGEND'S | ASTM D6319-00ae3 | LEGEND'S |
| Before aging<br>Small<br>Medium<br>Large<br>x-large | 14 min | 19.0 min | 500 min | 630min |
| After aging<br>22hours@100°C<br>Small<br>Medium<br>Large<br>x-large | 14 min | 19.0 min | 400 min | 530min |

### 3. Water Tight Test

The pinhole or leak testing, the sampling and testing conform to the test methods and AQL established by the manufacturer under their quality system acceptance criteria in 21 CFR 820.181.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 8 2003

JDA Tianjin Plastic Rubber Company, Limited C/O Mr. Chen Yuhong TUV Rheinland Beijing Office Rm 707 Avic Bldg. 2 Dong San Huan Nan Road Chaoyang District BEIJING 100022, P.R. CHINA

Re: K030529

Trade/Device Name: Legend (Brand) Nitrile Powder-Free Patient Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: April 23, 2003 Received: June 2, 2003

Dear Mr. Yuhong:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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## Page 2 - Mr. Yuhong

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Suser Runse

Susan Runner, DDS, MA Interim 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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1K030524

3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The information, data and labeling claims in the entire 510(k) submission must support and agree with the Indications for Use statement.

#### INDICATIONS FOR USE

Applicant:_ JDA (Tianjin) Plastic Rubber Co., Ltd.

510(k) Number (if known):_*

Device Name: __ Nitrile powder-free patient examination glove _

Indications For Use:

Nitrile powder-free 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.

Clim S. Lin

510(k) Number: K030529