VINYL PATIENT EXAMINATION GLOVES-POWDER FREE

K994098 · Evergreen Medical Produts (Jingxing) Co., Ltd. · LYZ · May 23, 2000 · General Hospital

Device Facts

• Record ID: K994098
• Device Name: VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
• Applicant: Evergreen Medical Produts (Jingxing) Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: May 23, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A patient examination glove is a disposable device intended for medical purpose worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Disposable, non-sterile, powder-free vinyl patient examination glove; intended for use by healthcare personnel to prevent cross-contamination between examiner and patient. Manufactured via PVC film formulation and double-dipping process; first dip in PVC paste resin; second dip in Poly Urethane (PU) resin emulsion to provide lubricant surface for donning/doffing. Available in small, medium, large, and extra-large sizes. Device provides physical barrier protection during clinical examinations.

Clinical Evidence

Bench testing only. Includes primary dermal irritation and guinea pig sensitization (Buehler) testing. Performance metrics include tensile strength (min 10.0 MPa), elongation (min 350%), and pinhole leak rate (under 2.5%).

Technological Characteristics

Vinyl (PVC) material; powder-free; ambidextrous; PU resin coating for lubrication. Dimensions and physical properties conform to ASTM D5250-99 and JIS-S-2045 standards. Non-sterile.

Indications for Use

Indicated for use by healthcare personnel as a disposable barrier worn on the hand or finger to prevent cross-contamination between the examiner and the patient.

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.

Submission Summary (Full Text)

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EVERGREEN MEDICAL PRODUCTS

No. 1, Evergreen Rd., The North of Beishimen Village, Xiaozuo Town, Jingxing County, Shijiazhuang City, Hebei 050306, China Fax: + (86 311) 236 0670 Tel: + (86 311) 236 1018, 236 1035

R 994613
**510 (K) SUMMARY**

Date: May 03, 2000 Total pages: 4

### 1.0 APPLICANT:

Evergreen Medical Products (Jingxing) Co., Ltd. No. 1, Evergreen Rd., The North of Beishimen Village, Xiaozuo Town, Jingxing County, Shijiazhuang City, Hebei 050306 China Tel: +(86 311) 236 1035, 236 0652 Fax: +(86 311) 236 0670 E-mail: [e-mail]

#### 2.0 Contact Person:

Doreen Feng Tel: +(86 311) 236 1035, 236 0652 Fax: +(86 311) 236 0670

## 3.0 DEVICE CLASS: II

PRODUCT CODE: Vinyl (Powder Free) - 80 LYZ

- 4.0SPECIFICATION: Glove, Patient Examination, Vinyl (Powder Free) Meet all the current specifications listed under ASTM Specification D 5250-99
## 5.0 DEVICE DESCRIPTION:

Glove, Disposable, Non-sterile, Patient Examination, Vinyl (Powder Free)

## 6.0 INDICATION FOR USE (INTENDED USE):

A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste, or environment.

## 7.0INNER SURFACE: Powder Free

## 8.0 BIOCOMPATIBILITY TESTING:

- -Primary Dermal Irritation in Rabbits
- Guinea Pig Sensitization (Buehler) -

Issued by Consumer Products Testing Co.

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No. 1, Evergreen Rd., The North of Beishimen Village, Xiaozuo Town, Jingxing County, Shijiazhuang City, Hebei 050306, China Fax: + (86 311) 236 0670 Tel: + (86 311) 236 1018, 236 1035

## 9.0 QUALITY CHARACTERISTICS

510 (K) Summary: Page 2

## SPECIFICATION OF VINYL GLOVES (Ambidextrous)

| Size<br>Spec. | Small | Medium | Large | Ex-Large | Test code |
|---------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|----------------------------|----------------------------|----------------------------|-------------------------------------|
| Circumference<br>of Palm (mm)<br>(Inch) | 178<br>6-3/4 | 210<br>7-3/4 | 218<br>8-1/2 | 230<br>9 | JIS-S-2045.509 |
| Total Length<br>(+/- 5 mm) | 240 | 245 | 245 | 245 | JIS-S-2045.5.9 |
| Length of<br>Fingers (mm)<br>Thumbs<br>Index Finger<br>Middle Finger<br>Ring Finger<br>Little Finger | 55<br>66<br>74<br>69<br>54 | 57<br>70<br>81<br>74<br>50 | 61<br>75<br>83<br>79<br>60 | 63<br>78<br>92<br>82<br>62 | JIS-S-2045.5.9 |
| Circumference<br>Fingers (mm)<br>Thumb<br>Index Finger<br>Middle Finger<br>Ring Finger<br>Little Finger | 63<br>56<br>59<br>56<br>50 | 71<br>64<br>66<br>63<br>57 | 78<br>70<br>72<br>69<br>62 | 83<br>74<br>76<br>73<br>66 | JIS-S-2045.5.9 |
| Tensile Strength<br>(Mpa) | Min.<br>10.0 | Min.<br>10.0 | Min.<br>10.0 | Min.<br>10.0 | JIS-S-2045.5.2 |
| Elongation (Min.) | 350% | 350% | 350% | 350% | JIS-S-2045.5.2 |
| Weight (g/pc) | 7.0 | 8.0 | 9.0 | 9.5 | +/- 0.2g |
| Thickness | Finger Tip<br>0.08 mm +/- 0.02 mm<br>Cuff<br>0.09 mm +/- 0.02 mm<br>Palm<br>0.15 mm +/- 0.02 mm | | | | |
| Quality<br>Assurance | Under 2.5% Pinhole Rate | | | | FDA Glove 1000ml<br>Water Leak Test |

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Image /page/2/Picture/0 description: The image shows the logo for Evergreen Medical Products Co., LTD. The logo is written in both Chinese and English. The Chinese characters are on top, and the English words are on the bottom. The English words are written in a bold, sans-serif font.

No. 1, Evergreen Rd., The North of Beishimen Village, Xiaozuo Town, Jingxing County, Shijiazhuang City, Hebei 050306, China Tel: +(86 311) 236 1018, 236 1035 Fax: +(86 311) 236 0670

510 (K) Summary: Page 3

## 10.0 MANUFACTURING PROCESS OF POWDER FREE VINYL GLOVES:

Image /page/2/Figure/4 description: This image shows a flowchart of the manufacturing process of powder-free vinyl gloves. The process starts with the material being inspected, then formulated into a PVC film, followed by air-free treatment. The gloves are then dipped in PVC paste resin, heated to 240 degrees Celsius, and dipped a second time in a P.U. tank before drying and heating again to 240 degrees Celsius.

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Image /page/3/Picture/0 description: The image shows the logo for Evergreen Medical Products Co., LTD. The logo includes the company name in both Chinese and English. Below the company name is the address: No. 1 Evergreen Rd, The North of Boishimon Village, Yiaozue Town.

No. 1, Evergreen Rd., The North of Beishimen Village, Xiaozuo Town, Jingxing County, Shijiazhuang City, Hebei 050306, China Tel: +(86 311) 236 1018, 236 1035 Fax: +(86 311) 236 0670

510 (K) Summary: Page 4

Note:

A second time dipping process is adopted to compensate for the lack of donning powder, (Second time dipping process: After the glove is formed on the mold, the second stage of process is exercised by dipping the glove into a Poly Urethane Resin Emersion. Poly Urethane resin emersion is in the category of polymer which contains silicon. The characteristic of Poly Urethane enable to coat a membrane on the gloves which makes the surface of the gloves more lubricant and hence more easy to be worn and to be took off.

Weight of all types of residual powder on medium size glove is 0 milligram per glove. The gloves are powder free and the process does not include any powder.

#### 11.0 CONCLUSION:

The vinyl Patient Examination gloves (powder free) manufactured by Evergreen Medical products (Jingxing) Co., Ltd. meet ASTM D5250-99 performance standard and meet pinhole requirements and labeling claims.

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of three wavy lines, which are meant to symbolize the human form.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2000

Ms. Doreen Fenq Evergreen Medial Products (Jingxing) Co. Ltd. #1, Evergreen Road, The North of Beishimen Village, Xiazuo Town, Jingxing County, Shijiazhuang City, Hebei 050306 CHINA

Re : K994098 Trade Name: Vinyl Patient Examination Gloves Powder-Free Regulatory Class: I Product Code: LYZ Dated: January 21, 2000 Received: May 8, 2000

Dear Ms. Feng:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Feng

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA deborized substantial equivalence of your device to a legally rinding or babbansaasic results in a classification for your marketed predication wour device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in regulagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on compriatee as (some with of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to the regulation encreted, "Arbidian" (2) CFR 807.97). Other general information on your responsibilities under the Act may be Intoined from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/6/Picture/0 description: The image shows the name of a company in both Chinese and English. The Chinese characters at the top read "長榮醫療用品有限公司". Below this, the English translation is written as "EVERGREEN MEDICAL PRODUCTS CO., LTD.". The text at the bottom reads "Villege Yiaочно Town".

No. 1, Evergreen Rd., The North of Beishimen Village, Xiaozuo Town, Jingxing County, Shijiazhuang City, Hebei 050306, China Fax: + (86 311) 236 0670 Tel: + (86 311) 236 1018, 236 1035

# INDICATION FOR USE STATEMENT

| Applicant: | Evergreen Medical Products (Jingxing) Co., Ltd. |
|----------------|-------------------------------------------------|
| 510(K) Number: | K944098 |
| Device Name: | Vinyl Patient Examination Gloves - Powder Free |

## Indication for use:

A patient examination glove is a disposable device intended for medical purpose worn on the examiner's hand or finger to prevent contamination between patient and examiner.

## Concurrence of CDRH Office of Device Evaluation (ODE)

Chiri AB IN

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_x994049

Prescription Use Per 21 CFR 801.109

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