LANFAN POWDER-FREE VINYL EXAM GLOVES

K072488 · Shanghai Lanfan Co., Ltd. · LYZ · Oct 19, 2007 · General Hospital

Device Facts

• Record ID: K072488
• Device Name: LANFAN POWDER-FREE VINYL EXAM GLOVES
• Applicant: Shanghai Lanfan Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Oct 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

Powder-free Vinyl Examination Glove is intended for single use for medical purposes and are worn on the hand of heath care and similar personnel to prevent contamination between the health care personnel and the patients.

Device Story

Disposable patient examination glove; manufactured from PVC material with PU coating to facilitate donning. Used by healthcare personnel in clinical settings to provide a barrier against infectious materials and contaminants. Device is non-sterile, single-use, and intended for over-the-counter use. Performance verified through non-clinical bench testing and biocompatibility assessments (skin irritation and sensitization).

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), demonstrating no irritation or sensitization.

Technological Characteristics

Material: PVC with PU coating. Form factor: Disposable examination glove. Standards: ASTM D5250-06. Biocompatibility: Tested for skin irritation and sensitization. No software or electronic components.

Indications for Use

Indicated for use as a disposable, single-use barrier glove worn on the hands or fingers by healthcare personnel to prevent cross-contamination between the user and patients.

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 EXAMINATION GLOVE (K052985)

Submission Summary (Full Text)

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## SHANGHAI LANFAN CO., LTD

202 Huaxia Bank Tower 256 Pudong Road South, Shanghai 200120 China Tel: [phone] Fax: [phone]

### ATTACHMENT IV: 510 (k) EXECUTIVE SUMMARY.

# 1072488

#### POWDER-FREE VINYL EXAMINATION GLOVE

UCT 1 9 2007

| Submitter's Name | Shanghai Lanfan Co., Ltd |
|---------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's address | 2002 Huaxia Bank Tower 256 Pudong Road<br>South, Shanghai 200120 China |
| Submitter's Telephone Number | [phone] |
| Submitter's Fax Number | [phone] |
| Name of Contact Person | Kaifeng Bei |
| Date of Preparation | August 1, 2007 |
| Name of Device | Powder-free Vinyl Exam Gloves, |
| Trade Name | Lanfan Brand and other customers Private<br>labeling |
| Common Name | Patient Examination Gloves, Vinyl |
| Classification Name | Patient Examination Gloves, Vinyl<br>Powder-free (per proposed 21 CFR 880.6250) |
| Device Classification | Class I |
| Regulation Number | 21 CFR 880.6250 |
| Panel | General Hospital (80) |
| Product Code | LYZ |
| Device Description | The Powder-free vinyl exam glove is a<br>disposable Class 1 medical device made<br>from PVC material and is intended to be<br>worn on the hands of health care personnel<br>for medical purpose to provide a barrier<br>against potentially infectious materials and<br>other contaminants. |
| Legally Marketed Device To Which<br>Equivalency is Being Claimed | Powder-free vinyl Exam gloves are<br>described in the 510 (k) notification are<br>substantially equivalent to the Class I patient<br>examination gloves, Vinyl, 80LYZ Powder<br>free by PU coating, that meets the current<br>ASTM D5250-06 "Standard Specification |
| Tel: [phone] Fax: [phone] | |
| | for Polyvinyl Examination Gloves for<br>Medical Application" |
| Predicate Device | A) K070149 POWDER-FREE VINYL<br>PATIENT EXAMINATION GLOVES,<br>MANUFACTURED BY: WUXI SHENZHOU<br>PLASTIC PRODUCTS CO., LTD. |
| | B) K052985 POWDER FREE VINYL<br>EXAMINATION GLOVE<br>MANUFACTURED BY: TG MEDICAL<br>(CHINA) INCORPORATION |
| Summary of Technological<br>Characteristics Compared to the<br>Predicate Device<br>Performance testing report | There are no different technological<br>characteristics. Gloves are made from PVC<br>material. |
| Intended Use of the Device | Powder-free Vinyl Examination Glove is<br>intended for single use for medical purposes<br>and are worn on the hand of heath care and<br>similar personnel to prevent contamination<br>between the health care personnel and the<br>patients. |
| Brief Discussion of Non clinical Tests | Testing is performed as per ASTM<br>D5250-06 and 21 CFR 800.20, gloves meet<br>all the current Specifications listed under the<br>ASTM D5250-06 Standard Specification for<br>Vinyl Examination Gloves.<br>Primary Skin Irritation testing in the rabbit<br>and delayed contact Sensitization testing in<br>the guinea pig indicate no irritation or<br>sensitization. |
| Brief Discussion of Clinical Tests | No new clinical tests were conducted under<br>this 510 (k) |
| Conclusions Drawn for the Non clinical<br>and Clinical Tests | Non clinical Laboratory and animal data<br>indicate that the powder free vinyl glove<br>meet all performance and biocompatibility<br>requirements. |
| Other Information Deemed Necessary by<br>FDA | Non Applicable |

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# SHANGHAI LANFAN CO., LTD

202 Huaxia Bank Tower 256 Pudong Road South, Shanghai 200120 China Tel: + 86-21-68865927 Fax: + 86-21-68866351

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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 circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle or bird-like figure with three horizontal lines above it, suggesting wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bei Kaifeng Operation Manager Shanghai Lanfan Company, Limited 2002 Huaxia Bank Tower 256 Pudong Road South Shanghai 200120 CHINA

OCT 1 9 2007

Re: K072488

Trade/Device Name: Powder-Free Vinyl Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: 1 Product Code: LYZ Dated: August 28, 2007 Received: September 6, 2007

Dear Bei Kaifeng:

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 premarketapproval 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 - Bei Kaifeng

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,

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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## SHANGHAI LANFAN

202 Huaxia Bank Tower 256 Pudong Road South, Shanghai 200120 China Tel: [phone] Fax: [phone]

#### ATTACHMENT I:INDICATION FOR USE

Applicant:

Shanghai Lanfan Co., Ltd

2002 Huaxia Bank Tower 256 Pudong Road South

Shanghai, 200120 China

## 510 (K) NUMBER (IF KNOWN): _ KO12488

INDICATIONS FOR USE:

A Powder-free Vinyl Patient Examination Glove is disposable device made of PVC material that coated with PU coating to facilitate donning and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials individual contaminants.

吴开峰

Bei Kaifeng (Operation Manager)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | |
|----------------------|--|
| (Per 21 CFR 801.109) | |

| (Division Sign Off) | |
|---------------------|--|
|---------------------|--|

| Over-The-Counter-Use | X |
|----------------------|---|
|----------------------|---|

Division of Anesthesiology, General Hospital
Infection Control, Dental Devices (Optional Format 1-2-96)

| 510(k) Number: | K970488 |
|----------------|---------|
|----------------|---------|