POWDER-FREE VINYL PATIENT EXAMINATION GLOVES COLORED (WHITE, YELLOW)

K051156 · Shijiazhuang Manful Light Industrial Products Co., · LYZ · Jun 14, 2005 · General Hospital

Device Facts

• Record ID: K051156
• Device Name: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES COLORED (WHITE, YELLOW)
• Applicant: Shijiazhuang Manful Light Industrial Products Co.,
• Product Code: LYZ · General Hospital
• Decision Date: Jun 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

powder free vinyl patient examination glove colored (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 vinyl patient examination glove; colored white or yellow; worn on examiner's hand or finger. Prevents cross-contamination between patient and examiner during medical procedures. Used in clinical settings by healthcare providers. Device functions as a physical barrier. No electronic or mechanical components.

Clinical Evidence

No clinical data. Substantial equivalence is based on non-clinical bench testing, including physical property dimensions, freedom from pinholes, powder residual levels, and biocompatibility (skin irritation and dermal sensitization) testing.

Technological Characteristics

Material: Vinyl. Form factor: Disposable patient examination glove (white/yellow). Standards: ASTM D5250-00e4 (dimensions, physical properties, powder residual), ASTM D6124-01 (powder residual), 21 CFR 800.20 (pinholes), ISO 10993-10 (biocompatibility). 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

• Powder-Free Vinyl Patient Examination Gloves (K042119)

Submission Summary (Full Text)

{0}------------------------------------------------

# C Summary

# JUN 1 4 2005

"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 PRODUCTS CO., LTD |
|--------------------------------|------------------------------------------------------------|
| Submitter's address : | NO.78 CANGSHI ROAD, JINZHOU CITY, HEBEI, 052260, 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: | 4 April 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: | Powder Free Vinyl Patient Examination Gloves, Colored<br>(White, Yellow) | |
|-------------------------|--------------------------------------------------------------------------------|--|
| Proprietary/Trade name: | Powder Free 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* powder free vinyl patient examination gloves (white, yellow) that meets all of the requirements of ASTM standard D 5250-0004.

Predicate device : Powder-Free Vinyl Patient Examination Gloves,. SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., LTD K042119 .

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

Device Description : powder free vinyl patient examination gloves (white, yellow) that meets all of the requirements of ASTM standard D 5250-00t4.

#### Section C Page 1of 2

{1}------------------------------------------------

K05 1156

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

Device Intended Use: powder free vinyl patient examination glove colored (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 powder free vinyl patient examination gloves, 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 Residual | ASTM standard D 5250-00e4 | Meets |
| | and D6124-01 | <2mg/glove |
| Biocompatability | Primary Skin Irritation in<br>rabbits | 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 .

Powder free vinyl patient examination gloves (white, yellow) meet requirements per ASTM D5250-00-4, 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 Powder Free Vinyl Patient Examination Gloves meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims .

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 AND HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure.

JUN 1 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shijiazhuang Manful Light Industrial Products Company C/O Mr. Chu Xiaoan TUV Rheinland Beijing Office Rm. 1606, Bldg. 1 Jianxiang Yuan No 209 Bie Si Huan ZhongRoad Haidian District, Beijing, CHINA 100083

Re: K051156

Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, Colored (White, Yellow) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: April 4, 2005 Received: May 4, 2005

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.

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.

{3}------------------------------------------------

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); 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/industry/support/index.html.

Sincerely yours.

Quettie y. Michael Davis.

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

{4}------------------------------------------------

# INDICATIONS FOR USE

Applicant: SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., LTD

510(k) Number (if known): K051156

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

INDICATIONS FOR USE

Powder free 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)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Zada L. Mighlick 4/14/15

Anesthesiology, General Hospital Infection Control. D

510(k) Number: K151132