POWDERED VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE, YELLOW)

K051924 · Shijiazhuang Manful Light Industrial Products Co., · LYZ · Sep 2, 2005 · General Hospital

Device Facts

• Record ID: K051924
• Device Name: POWDERED VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE, YELLOW)
• Applicant: Shijiazhuang Manful Light Industrial Products Co.,
• Product Code: LYZ · General Hospital
• Decision Date: Sep 2, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

powdered vinyl patient examination glove (white, yellow) 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 gloves; white or yellow color. Worn by healthcare examiners on hands or fingers; barrier protection to prevent contamination between patient and examiner. Device functions as physical barrier; non-sterile. Performance verified against ASTM D5250-00e4 standards for dimensions, physical properties, and powder content; 21 CFR 800.20 for pinhole freedom; ISO 10993-10 for biocompatibility (skin irritation/sensitization).

Clinical Evidence

No clinical data. Bench testing only, including ASTM D5250-00e4 compliance, water leak testing for pinhole AQL per 21 CFR 800.20, and biocompatibility testing (primary skin irritation and dermal sensitization in animal models).

Technological Characteristics

Vinyl material; powdered; non-sterile. Dimensions and physical properties meet ASTM D5250-00e4. Pinhole AQL meets 21 CFR 800.20. Biocompatibility per ISO 10993-10.

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 Vinyl Patient Examination Gloves (K042120)

Submission Summary (Full Text)

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## SEP - 2 2005 Premarket Notification 【510(K)】 Summa

"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: ______________________________________________________________________________________________________________________________________________

#### 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 : | SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL<br>PRODUCTS CO., LTD | |
|--------------------------------|---------------------------------------------------------------|--|
| Submitter's address : | NO.78 CANGSHI ROAD, JINZHOU CITY, HEBEI, 052260,<br>P.R.CHINA | |
| Phone number : | (86)0311-4318269 | |
| Fax number : | (86)0311-4322592 | |
| Name of contact person: | Mr. Guo Huanqiang | |
| Date the summary was prepared: | 15 August 2005 | |

## [(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,Colored<br>(White, Yellow) |
|-------------------------|-----------------------------------------------------------------------------|
| Proprietary/Trade name: | 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: | LYZ |

## [(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, yellow) that meets all of the requirements of ASTM standard D 5250-00-4.

Predicate device : Powdered Vinyl Patient Examination Gloves, Powdered Vinyl Patient Examination Gloves,K042120

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

Device Description : powdered vinyl patient examination gloves (white, yellow) that meets all of the requirements of ASTM standard D 5250-00-3.

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Device Intended Use: powdered vinyl patient examination glove (white, yellow) 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, yell low) 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<br>rabbits | <10mg/dm2 |
| | | Passes |
| | | Not a Primary Skin Irritation |
| | Dermal sensitization in the<br>guinea pig | Passes |
| | | 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, yellow) meet requirements per ASTM D5250-0054, 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 Powdered Vinyl Patient Examination Gloves (White, yellow) neet 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 is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure with three curved lines representing its wings or body. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 2 2005

Shijiazhuang Manful Light Industrial Products Co., Ltd. C/O Mr. Chu Xiaoan Room 1606 Bldg. 1. Jianxiangyuan No. 209 Bei Shi Huan Zhong Road Haidian District Beijing, CHINA 100083

Re: K051924/S001

Kost /24/2001
Trade/Device Name: Powdered Vinyl Patient Examination Gloves, Colored (White, Yellow) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: August 22, 2005 Received: August 22, 2005

Dear Mr. Xiaoan:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becated by the device is substantially equivalent (for the relerenced above and nave decemblical to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate conmiseree pror to that have been reclassified in accordance with the provisions of Anticincine, of to devroes that having Act (Act) that do not require approval of a premarket inc Federal I ood, Drug, that Countine , therefore, market the device, subject to the general approval application (11.2 1). The general controls provisions of the Act include controls provisions of the rion from 2007 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 If your device is classified (see above) in the secured. Existing major regulations affecting (FMA), it may of subject to Sach addini Fleeteral Regulations, Title 21, Parts 800 to 898. In your device can be found in the Oods to receint concerning your device in the Federal Register.

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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 mean that FDA nas made a decemmanon that your ministered by other Federal agencies. of the Act of ally rederal statutes and regulations, but not limited to: registration You music comply with an the Fee s required (21 CFR Part 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gract 800); and i and listing (21 CFR Fall 807), laocimig (21 CFR Part 82), on (21 CFR Part 820); and if requirements as set form in the quality Systems (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 5 10(k)
19 a This letter will anow you to begin maneting your dence of your device to a a premarket notification. The I DA miding of basical on 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),
All and Career and Career and 10 Career and 10 companse the regulation If you desire specific advice for your de recolor at [phone]. Also, please note the regulation please contact the Office or Comphanes are (210) - 11 (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general miorination on Joan Copsumer Assistance at its toll-free Division of Sman 2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Syletta Y. Michael Orns.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control Center and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE

510(k) Number (if known):K051924

Device Name: Powdered Vinyl Patient Examination Gloves, Colored (White, Yellow)

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.

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

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

S, LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) (Division Sign-Off) urrence of CDRH, Office of Device Evaluation (ODE) Division of Anesthesiology, General Hospital Infection Control, Dental De

510(k) Number: A 051924