VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED)

K083600 · Quantum Co., Ltd. · LYZ · Feb 19, 2009 · General Hospital

Device Facts

• Record ID: K083600
• Device Name: VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED)
• Applicant: Quantum Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Feb 19, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A Powder-free vinyl Examination glove, 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 the patient and examiner.

Device Story

Disposable powder-free vinyl examination glove; manufactured from PVC resin, DINP plasticizers, Ca-Zn stabilizer, and TXIB; coated with polyurethane to facilitate donning. Used in clinical settings by healthcare providers as a protective barrier against infectious materials and contaminants. Device provides physical separation between examiner and patient to reduce cross-contamination risk.

Clinical Evidence

No clinical data. Bench testing performed per ASTM D5250-06 and 21 CFR 800.20. Biocompatibility testing included primary skin irritation (rabbit) and delayed contact sensitization (guinea pig), showing no irritation or sensitization.

Technological Characteristics

Material: PVC resin, DINP plasticizers, Ca-Zn stabilizer, TXIB. Coating: Polyurethane. Form factor: Disposable, powder-free, clear (non-colored) vinyl glove. Standards: Meets ASTM D5250-06.

Indications for Use

Indicated for use by medical examiners to be worn on the hand or finger to provide a barrier against infectious materials and contaminants, preventing 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 (K070149)
• POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K073193)

Submission Summary (Full Text)

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

K083600

## Executive Summary of

FEB 1 9 2009

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

| Submitter's Name | Quantum Co., Ltd |
|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's address | No. 2-3-18 Hua Sheng Yuan Park, Linzi,<br>Shandong 255410 China |
| Submistter's Telphone Number | [phone] |
| Submiter's Fax Number | [phone] |
| Name of Contact Person | Lijuan Wang |
| Date of Preparation | November 20th, 2008 |
| Device Description | The Powder-free vinyl Examination<br>glove, clear (Non-colored) is disposable<br>device made PVC resin and plasticizers<br>(DINP), Ca-Zn stabilizer, TXIB into film,<br>coated with Polyurethane to facilitate<br>donning and it intended to be worn on<br>the hand of finger(s) for medical purpose<br>to provide a barrier against potentially<br>infectious materials and other<br>contaminants. |
| Legally Marketed Device To Which<br>Equivalency is Being Claimed | Powder-free vinyl Examination glove,<br>clear (Non-colored) is described in the<br>510 (k) notification are substantially<br>equivalent to the Class I patient<br>examination gloves, Vinyl, 80LYZ coated<br>with Polyurethane dusting powder, that<br>meets the current ASTM D5250-06<br>"Standard Specification for Polyvinyl<br>Examination Gloves for Medical<br>Application" |
| Predicate Device | A) K070149 POWDER-FREE VINYL<br>PATIENT EXAMINATION GLOVES<br>MANUFACTURED BY: WUXI<br>SHENZHOU PLASTIC PRODUCTS<br>CO., LTD. |
| Predicate Device | B) K073193 POWDER-FREE VINYL<br>PATIENT EXAMINATION GLOVES |
| | MANUFACTURED BY: SHIJIAZHUANG<br>PROSPEROUS PLASTIC CO., LTD. |
| Summary of Technological<br>Characteristics<br>Compared<br>to<br>the<br>Predicate Device<br>Performance testing report | Technological characteristics. Gloves are<br>made from PVC and DINP compound<br>and the initial products are powder free<br>vinyl<br>examination<br>gloves,<br>clear<br>(non-colored). |
| Intended use of the Device | A Powder-free vinyl Examination glove,<br>clear (Non-colored) is a disposable<br>device intended for medical purposes<br>that is worn on the examiner's hand or<br>finger to prevent contamination between<br>patient and examiner. |
| Brief Discussion of Nonclinical Tests | Testing is performed as per ASTM<br>D5250-06 and 21 CFR 800.20, gloves<br>meet all the current Specifications listed<br>under the ASTM D5250-06 Standard<br>Specification for Vinyl<br>Examination<br>Gloves.<br>Primary Skin Irritation testing in the<br>rabbit and delayed contact Sensitization<br>testing in the guinea pig indicate no<br>irritation or sensitization. |
| Brief Discussion of Clinical Tests | No new clinical tests were conducted<br>under this 510 (k) |
| Conclusions Drawn for the Non clinical<br>and Clinical Tests | Non-clinical Laboratory and animal data<br>indicate that the pre-powdered<br>vinyl<br>products meet all performance<br>and<br>biocompatibility requirements. |
| Other Information Deemed Necessary by<br>FDA | Non Applicable |

: 100

~:

:

.

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

100 - 100 -

.. . . . . .

:

.

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

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### FEB 1 9 2009

Ms. Lijuan Wang Operation Manager Quantum Company, Limited Number 2-3-18 Hua Sheng Yuan Park Linzi Shandong 255410 CHINA

K083600 Re:

> Trade/Device Name: Powder-Free Vinyl Examination Gloves, Clear (Non-Colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: February 1, 2009 Received: February 4, 2009

Dear Ms. Wang:

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 - Ms. Wang

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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Mishranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Sinceraly yours,

Anthony D. Watson for
Ginette Y. Michaud, M.D.
Acting Director.
Division of Anesthesiology, General Hospital,
Infection Control and-Dental Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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

QUANTUM CO.,LTD. No. 2-3-18 Hua Sheng Yuan Park, Linzi, Shandong 255410 China Tel: [phone] Fax: [phone]

Attachment

# Indications for Use

510(k) Number (if known): _K083600

Device Name: _Powder-Free, Vinyl Examination Gloves, Clear (Non-Colored)

Indications for Use:

Powder-free vinyl Examination glove, 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 t patient and examiner. 2 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1

Yours faithfully

signature

Ms. Lijuan Wang Operation Manager Date: Jan 29, 2009

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shuli A. Murphy, MD
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K083606

Page of