VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED

K994099 · Evergreen Medical Produts (Jingxing) Co., Ltd. · LYZ · Apr 12, 2000 · General Hospital

Device Facts

• Record ID: K994099
• Device Name: VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED
• Applicant: Evergreen Medical Produts (Jingxing) Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Apr 12, 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, ambidextrous vinyl patient examination glove; pre-powdered with USP absorbable dusting powder (modified starch). Worn by healthcare personnel to prevent cross-contamination between examiner and patient/environment. Features straight fingers, rolled rim, and natural color. Available in small, medium, large, and extra-large sizes. Manufactured from polyvinyl chloride, di-2-ethylhexyl phthalate, and other stabilizers. Used in clinical settings; provides a physical barrier. Performance verified via water leak testing, tensile strength, and elongation measurements per ASTM D5250-99.

Clinical Evidence

Bench testing only. Evidence includes physical property testing (tensile strength, elongation), dimensional analysis, and pinhole/leakage testing per ASTM D5250-99 and 21 CFR 800.20. Biocompatibility testing included primary dermal irritation in rabbits and guinea pig sensitization (Buehler).

Technological Characteristics

Material: Polyvinyl chloride (45.90%), Di-2-Ethylhexyl Phthalate (45.90%), 2,2,4-Trimethyl-1,3-Pentanediol (4.50%), Calcium/Zinc Stearates (2.30%), Epoxidized Soyabean Oil (0.50%). Lubricant: USP absorbable dusting powder (<120 mg/glove). Dimensions: 240-245mm length, 0.08-0.15mm thickness. Standards: ASTM D5250-99, ASTM D3578, ISO 2859. Non-sterile. Ambidextrous, rolled rim.

Indications for Use

Indicated for use by healthcare personnel on hands or fingers to prevent cross-contamination between the patient and the 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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains Chinese characters followed by the English text "EVERGREEN MEDICAL PRODUCTS CO., LTD." The Chinese characters are above the English text. The text is in a sans-serif font and is black on a white background. The image appears to be a company logo or heading.

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

APR 1 2 2000

Date: Feb. 22, 2000 Total pages: 3

#### 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: JY

PRODUCT CODE: Vinyl (Pre-Powdered) - 80 LYZ

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

Glove, Disposable, Non-sterile, Patient Examination, Vinyl (Pre-powdered)

#### 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: Pre-powdered

#### 8.0 BIOCOMPATIBILITY TESTING:

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

Issued by Consumer Products Testing Co.

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Image /page/1/Picture/0 description: The image shows the name of a company in both Chinese and English. The Chinese characters are at the top, and the English name, "EVERGREEN MEDICAL PRODUCTS CO., LTD." is below. The English name is in a bold, sans-serif font and has a textured fill. There is a line underneath the English name.

No. 1, Evergreen Rd., The North of Beishimen Village, Xiaozuo Town, Jingxing County, Shijiazhuang City, Hebei 050306, China Fax: + (86 311) 236 0670 el: + (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 name of a company in both Chinese and English. The Chinese characters at the top read "Chang Rong Medical Products Co., Ltd." Below this, the English translation "EVERGREEN MEDICAL PRODUCTS CO., LTD." is displayed in a bold, outlined font. The English text is set against a textured background, adding visual interest to the company's name.

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

510 (K) Summary: Page 3

#### 10.0 CONCLUSION:

The vinyl Patient Examination gloves (Pre-powdered) manufactured by Evergreen Medical products (Jingxing) Co., Ltd. meet ASTM D5250-99 Standard and meet pinhole requirements and labeling claims.

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Image /page/3/Picture/0 description: The image shows the text "EVERGREEN MEDICAL PRODUCTS CO., LTD." in a bold, sans-serif font. Above this text is the same company name in Chinese characters. The English text is underlined with a thin black line.

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

Total pages: 6

# GENERAL QUALITY CONTROL SCHEME

#### 1.0 PRODUCT

Vinyl Patient Examination Gloves Pre-Powdered, Non-Sterile

#### 2.0 INTENDED USE

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

#### 3.0 DONNING POWDER

U. S. P. Absorbable Dusting Powder, Neutral pH

- U. S. FDA approved under ANDA (Abbreviated new Drug Application 809535)
U. S. FDA Medical Device Establishment manufacturing Registration Number for manufacturing site.

Name of supplier of USP powder: Shieh-Tai Chemical & Starch Co., Ltd. Brand name of USP powder: Modified Starch Extra 226.

#### 4.0 COMPONENTS

| Polyvinyl Chloride | 45.90% |
|-----------------------------------|-----------------------|
| Di-2-Ethylhexyl Phthalate | 45.90% |
| 2,2,4-Trimethyl-1, 3-Pentanediol | 4.50% |
| Calcium, Zinc Sterates | 2.30% |
| Epoxidized Soyabean Oil | 0.50% |
| Absorbable Powder for Lubrication | < 120 milligram/glove |

#### 5.0 SHAPE

Straight fingers, thumb and fingers in one plane, fist either hand, rolled rim

#### 6.0 SIZE

Small (S), Medium (M), Large (L), Extra-Large (XL)

#### 7.0 COLOR

Natural color, no color additive

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Image /page/4/Picture/0 description: The image shows the text "EVERGREEN MEDICAL PRODUCTS CO., LTD." in a large, outlined font. Above this text is the same company name written in Chinese characters. The text is centered and takes up most of the image. The background is a grainy texture.

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

#### 8.0 MARKING

General Quality control scheme: Page 2

Gloves are marked to designated size

#### 9.0 PACKING

As per packing specification

#### 10.0 LABELING

#### 10.1Control Number

Each packing unit (dispenser box) and outer cartons bears a control number Example: EVX1991230888

EV .................................... Abbreviation of factory name

XI99 ............................. Production month and year

123 ........................................ Internal running order number

0888 .............................. Case number

#### 10.2Manufacturing dating

Each packing unit (dispenser box) or outer cartons bears the manufacturing dating.

#### 10.3Caution words on the box

"Caution: Users should consider the circumstance of use in deciding whether to remove residual powder from gloves after donning. Powder can be removed by thoroughly wiping gloves with a sterile wet sponge, sterile wet towel, or other effective method."

#### 11.0 PERFORMANCE REQUIREMENTS FOR QUALITY CHARACTERISTICS

For reference purpose in accordance with ISO 2859 Sampling procedures and Tables for Inspection by Attribute.

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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 el: + (86 311) 236 1018, 236 1035

General Quality Control Scheme: Page 3

#### 12.0 QUALITY CHARACTERISTICS

| Description | Specification | Assurance Action |
|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Dimensions<br>Overall Length | 240+/- 10 mm | Test method A1<br>Dimensional control<br>Inspection level S-2<br>AQL 2.5 |
| Width | Small 83 +/- 5 mm<br>Medium 94 +/- 5 mm<br>Large 105 +/- 5 mm<br>Ex-Large 114 +/- 5 mm | |
| Thickness<br>(Double wall) | Finger 0.48 mm Max.<br>Cuff 0.20 mm Min. | |
| Chemical Properties<br>Inside pH | 7 +/- 1 | Test method A2<br>Inspection level S-2<br>AQL 2.5 |
| Powder level<br>Inside<br>Outside | max. 2.5 +/- 1.0 by weight<br>max. 1.0% by weight | Test method A3<br>Inspection level S-2<br>AQL 2.5 |
| Physical Properties<br>Before Aging<br>Tensile Strength<br>Elongation at break | Min. 10 Mpa<br>Min. 350% | Test method A4<br>Inspection level S-2<br>AQL 2.5 |
| After Aging<br>(70°C, 166 hours<br>Tensile Strength<br>Elongation at break | Test method A4<br>Min. 10 Mpa<br>Min. 350% | Inspection level S-2<br>AQL 2.5 |

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Image /page/6/Picture/0 description: The image contains Chinese characters at the top and the English text "EVERGREEN MEDICAL PRODUCTS CO., LTD." below. The Chinese characters appear to be a company name, likely the same as the English text. The text is bold and in a sans-serif font, with a slightly distressed or textured appearance. The overall image seems to be a company logo or letterhead.

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

General Quality Control Scheme: Page 4

#### 13.0 INTERNAL ATTRIBUTIVE RELEASE INSPECTION

Examination

Sampling for examination accordance with ISO 2859 Sampling Procedures and Tables for Inspection by Attributes.

Unit for Examination: one (1) glove

If several defects are found on one glove, only the most serious defect (i. e. lowest category) is evaluated. The acceptance criteria are based on the number of defective observed in a sample.

#### 14.0 PIN HOLE AND VISUAL DEFECTS

#### Assurance Action

Sampling Inspection by Air inflation and cuff sorting (method A5), inspection level II Performance requirements:

| Category of Defect | AQL |
|--------------------|-----|
| 1 | 1.0 |
| 2 | 2.5 |

#### 15.0 FINAL GLOVE RELEASE

#### 15.1 Assurance Action

U. S. FDA Test Method for Leakage Defects published in the Federal Registration of Nov. 31, 1989 (21 CFR Part 800.20)

#### 15.2 Sampling Inspection

AQL 1.5 for leaks AQL 4.0 for leaks and visual defects aggregated. Inspection level 1, normal inspection, multiple sampling

#### 16.0 PACKAGING, MARKING, GOOD DELIVERY INSPECTION

Assurance Action Set-up and patrol inspection at packaging Supervision of vehicle or vessel loading

#### 17.0 GOOD MANUFACTURING PRACTICE

The gloves are manufactured in compliance with the current Good manufacturing Practice (GMP) requirements in the United States of America as appropriate for patient examination gloves.

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Image /page/7/Picture/0 description: The image contains the name of a company in both Chinese and English. The Chinese characters at the top read "Chang Rong Medical Products Co., Ltd." The English translation below reads "EVERGREEN MEDICAL PRODUCTS CO., LTD." The English text is in a bold, outlined font.

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

General Quality Control Scheme: Page 5

#### 18.0 MICROBIOLOGICAL CLEANLINESS CONTROL

The bioburden of the finished gloves are monitored and recorded. Unusual contaminants are identified. It is attempted to determine their sources and eliminating or reducing their impact.

#### 19.0 CAUTION

Non-sterile examination gloves are used in a variety of circumstances, including procedures where the surface of the glove contacts wounds, body cavities, or other possible routes of contamination. If conditions warrant, the user may wish to minimize the risk of infection. In this case, we recommend the decontamination of the gloves prior to use by disinfectants or other effective methods.

#### 20.0 STORAGE

According to ISO 2230

Keep storage areas cool, dry and dust free, avoid ventilation. Protect gloves against ultraviolet light sources, as sunlight and oxidizing agents. Cooper ions discolor the gloves.

#### 21.0 REFERENCED TEST METHODS

#### A. 1 Physical Dimensions

Adherence to ASTM D 5250, for length and width press ruler on the flat glove. Measure double film thickness of an intact glove, and report the median of not less than three measurements at different locations.

#### A. 2 Surface pH of Glove Inside

Warm 50 ml distilled water to 38 +/- 2℃. Fill the glove and twist to close the cuff end. Wash the glove inside and squeezing. Pour content into a beaker and measure pH.

#### A. 3 Residual powder

5 air dried gloves are weighted together and afterwards rinsed in water to remove Then the gloves are air dried to constant weight for approximately 12 hours. powder. The quantity of powder is determined by the decrease in weight. Limiting values apply to the median of at least 10 results.

#### A. 4 Physical Requirements

Adherence to ASTM D 3578. Use same glove to compare before and after aging. Report the median of not less than 5 test results for each requirements.

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Image /page/8/Picture/0 description: The image shows the logo of Evergreen Medical Products Co., LTD. The logo is in both Chinese and English. The Chinese characters are on top, and the English words are on the bottom. The English words are in a sans-serif font and are underlined.

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

General Quality Control Scheme: page 6

#### A. 5 Air Inflation and Cuff Test

Partial adherence to BS 4005, Single Use Sterile Surgical Rubber Gloves, Appendix C. Inflate glove with air approximately to a diameter of 200 mm and fan in front of face. Listen for air leakage and feel it. Visually examine for defects. Stretch cuff next to edge and inspect visually. Validated against FDA water leak test.

#### 22.0 LIST OF DEFECT

| Category | Defect | Test method |
|----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| 1 | Holes, cuts, tears | Visual, Sensual |
| 2 | Pleats and Lumps in critical area<br>Contents not as specified<br>(size, former type)<br>Dirty/foreign spot on surface more than<br>2 per glove or > 0.5 mm<br>Embedded particles > 1 mm, more than 2 per glove<br>Thin spots<br>Discoloration, blooming<br>Torn, broken or open bead<br>Pleats, lumps in non-critical area | Visual<br>Visual<br>Visual |

- End of document -

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Image /page/9/Picture/2 description: The image shows a black and white logo of the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three wing-like shapes. The words "DEPARTMENT OF HEALTH & H.S." are arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### APR 1 2 2000

Ms. Doreen Feng Evergreen Medical Products (Jingxing) Co., Ltd. No. 1, Evergreen Road The North of Beishimen Village Xiaozuo Town, Jingxing County Shijiazhuang City, Hebei 050306 CHINA

Re : K994099 Vinyl Patient Examination Gloves- Pre-Trade Name: powdered Requlatory Class: I Product Code: LYZ February 22, 2000 Dated: Received: April 3, 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 The general controls provisions of the Act 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) requlation (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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your

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Page 2 - Ms. Feng

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.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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

Timo v A Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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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

# INDICATION FOR USE STATEMENT

| Applicant: | Evergreen Medical Products (Jingxing) Co., Ltd. |
|----------------|-------------------------------------------------|
| 510(K) Number: | K994099 |
| Device Name: | Vinyl Patient Examination Gloves - Pre-powdered |

#### 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)

Claire S. Lim

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 5100k) Number .

Prescription Use _ Per 21 CFR 801.109

Over-The-Counter OR