BLUE SAIL (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES

K032783 · Zibo Blue Sail Plastic & Rubber Products Co., Ltd. · LYZ · Nov 13, 2003 · General Hospital

Device Facts

• Record ID: K032783
• Device Name: BLUE SAIL (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES
• Applicant: Zibo Blue Sail Plastic & Rubber Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Nov 13, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Powdered vinyl 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 powdered vinyl patient examination glove; worn on examiner's hand or finger; prevents contamination between patient and examiner; used in clinical settings; provides barrier protection.

Clinical Evidence

No clinical data. Substantial equivalence is based on non-clinical bench testing including physical property testing, pinhole leak testing, and biocompatibility assessments (primary skin irritation and dermal sensitization) per ASTM and FDA standards.

Technological Characteristics

Material: Vinyl. Standards: ASTM D5250-00e4, ASTM D6124-01, 21 CFR 800.20, ISO 10993-10. Form factor: Powdered patient examination glove. Non-sterile.

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

• powdered synthetic vinyl patient examination gloves, Shijiazhuang Eversharp Plastics Products Co., Ltd. (K011884)

Submission Summary (Full Text)

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# C Summary

NOV 1 3 2003

"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: 1032783 ." (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 : | Zibo Blue Sail Chemical Co., Ltd |
|--------------------------------|--------------------------------------------------------------------------------|
| Submitter's address : | Qilu Chemical Industrial Area, Zibo City, Shandong Province, 255414, P.R.China |
| Phone number : | (86)533-7486199 |
| Fax number : | (86)533-7481177 |
| Name of contact person: | Liu Wenjing |
| Date the summary was prepared: | 3 September 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: | Powdered Vinyl Patient Examination Gloves, White (non-colored) |
|-------------------------|-----------------------------------------------------------------------------------------------|
| Proprietary/Trade name: | Blue Sail (Brand) Powdered Vinyl Patient Examination Gloves<br>Other clients private labeling |
| Common Name: | 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* powdered vinyl patient examination gloves , white (non-colored) that meets all of the requirements of ASTM standard D 5250-0064.

Predicate device : powdered synthetic vinyl patient examination gloves, Shijiazhuang Eversharp Plastics Products Co., Ltd. K011884 .

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

Device Description : powdered vinyl patient examination gloves, white (non-colored) that meets all of the requirements of ASTM standard D 5250-004.

#### Page 1of 2 Section C

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

Device Intended Use: powdered vinyl patient examination glove, white (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 powdered vinyl patient examination gloves, white (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 5250-00e4. | Meets |
| Physical Properties | ASTM standard D 5250-00e4. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Amount | ASTM standard D 5250-00e4 | Meets |
| Biocompatability | Primary Skin Irritation in rabbits | <10mg/dm2<br>Passes<br>Not a Primary Skin Irritation |
| | Dermal sensitization in the guinea 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 .

Powdered vinyl patient examination gloves , white (non-colored) meet requirements per ASTM D5250-0064, 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 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 Blue Sail (Brand) Powdered Vinyl Patient Examination Gloves , White (non-colored) meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims .

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 1 3 2003

Zibo Blue Sail Chemical Corporation Limited C/O Ms. Yuhong Chen Tuv Rheinland Beijing Office Rm 707, AVIC Bldg, No. 2 No. 2 Dong San Huan Nan Road Chaoyang District, Beijing, 100022, P.R. CHINA

Re: K032783

Trade/Device Name: Blue Sail (Brand) Powdered Vinyl Patient Examination gloves, White (Non-Colored) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: September 3, 2003 Received: September 8, 2003

Dear Ms. Chen:

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.

Chue L

Chiu Lin, Ph.D. 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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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: Zibo Blue Sail Chemical Co.,Ltd.

510(k) Number (if known): * KO32783 Blue Sail (Brand) Device Name: Powdered Vinyl Patient Examination Gloves, White(non-colored)

Indications For Use:

Powdered vinyl 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.

Susanna F. Bourud

nesthesiology, General Hospital, Infection Control. Dental

510(k) Number:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)